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Zitronensäure und ihre Alkalisalze [MAK Value Documentation in German language, 2018]


Hartwig, A; MAK Commission; Arand, Michael; et al (2018). Zitronensäure und ihre Alkalisalze [MAK Value Documentation in German language, 2018]. The MAK Collection for Occupational Health and Safety, 3(2):846-859.

Abstract

The German Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area has re‐evaluated citric acid [77‐92‐9] and its alkali metal salts, considering all toxicological endpoints.

The critical effect of citric acid is the irritation of the respiratory tract with an acute LOAEC of 225 mg/m3 in humans and 81 mg/m3 in guinea pigs. At this concentration coughing is induced due to the lowering of the pH value. The NOAEC in guinea pigs is 31 mg/m3, the corresponding NOAEC in humans is not known. Studies with repeated inhalation are not available. Therefore, the maximum concentration at the workplace (MAK value) has been set by analogy with the MAK value for phosphoric acid of 2 mg/m3 as inhalable fraction. Since a local effect is critical, Peak Limitation Category I is designated. The excursion factor of 2 is set by analogy with phosphoric acid.

The alkali metal salts of citric acid are not irritating, which precludes setting the same MAK value for the salts as for citric acid. However, a higher MAK value cannot be established because the systemic NOAEL is unclear. Therefore, no MAK value can be set for the alkali metal salts of citric acid.

The oral NOAEL for developmental toxicity in rats, mice, rabbits and hamsters is higher than 200 mg citric acid/kg body weight, which after toxicokinetic scaling corresponds to more than 200 mg/m3 at the workplace. Therefore, damage to the embryo or foetus is unlikely when the MAK value is observed and citric acid is assigned to Pregnancy Risk Group C.

Citric acid does not possess a relevant genotoxic potential in vivo. The same is assumed for its alkali metal salts. There are no valid carcinogenicity studies with citric acid. A tumour promoting effect of sodium citrate but not citric acid in the rat urinary bladder is due to excessively high sodium concentration in the urine and is therefore not relevant for humans at the workplace.

According to skin absorption models, percutaneous absorption of citric acid does not contribute significantly to systemic toxicity. The same is assumed for its alkali metal salts. Citric acid and its alkali metal salts are not sensitizing to skin or airways.

Abstract

The German Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area has re‐evaluated citric acid [77‐92‐9] and its alkali metal salts, considering all toxicological endpoints.

The critical effect of citric acid is the irritation of the respiratory tract with an acute LOAEC of 225 mg/m3 in humans and 81 mg/m3 in guinea pigs. At this concentration coughing is induced due to the lowering of the pH value. The NOAEC in guinea pigs is 31 mg/m3, the corresponding NOAEC in humans is not known. Studies with repeated inhalation are not available. Therefore, the maximum concentration at the workplace (MAK value) has been set by analogy with the MAK value for phosphoric acid of 2 mg/m3 as inhalable fraction. Since a local effect is critical, Peak Limitation Category I is designated. The excursion factor of 2 is set by analogy with phosphoric acid.

The alkali metal salts of citric acid are not irritating, which precludes setting the same MAK value for the salts as for citric acid. However, a higher MAK value cannot be established because the systemic NOAEL is unclear. Therefore, no MAK value can be set for the alkali metal salts of citric acid.

The oral NOAEL for developmental toxicity in rats, mice, rabbits and hamsters is higher than 200 mg citric acid/kg body weight, which after toxicokinetic scaling corresponds to more than 200 mg/m3 at the workplace. Therefore, damage to the embryo or foetus is unlikely when the MAK value is observed and citric acid is assigned to Pregnancy Risk Group C.

Citric acid does not possess a relevant genotoxic potential in vivo. The same is assumed for its alkali metal salts. There are no valid carcinogenicity studies with citric acid. A tumour promoting effect of sodium citrate but not citric acid in the rat urinary bladder is due to excessively high sodium concentration in the urine and is therefore not relevant for humans at the workplace.

According to skin absorption models, percutaneous absorption of citric acid does not contribute significantly to systemic toxicity. The same is assumed for its alkali metal salts. Citric acid and its alkali metal salts are not sensitizing to skin or airways.

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Additional indexing

Item Type:Journal Article, not_refereed, original work
Communities & Collections:04 Faculty of Medicine > Institute of Pharmacology and Toxicology
07 Faculty of Science > Institute of Pharmacology and Toxicology
Dewey Decimal Classification:570 Life sciences; biology
610 Medicine & health
Language:German
Date:24 April 2018
Deposited On:21 Nov 2019 14:31
Last Modified:05 Dec 2019 08:23
Publisher:Wiley-VCH Verlag
ISSN:2509-2383
ISBN:9783527600410
OA Status:Closed
Publisher DOI:https://doi.org/10.1002/3527600418.mb7792kskd0065

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