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EC number: 257-573-7 | CAS number: 51981-21-6
GLDA-Na4 is not irritating to the rabbit skin and eye, and to the respiratory tract of rats.
A study was performed to assess the irritancy potential of the test material, GBS-5, to the skin of the New Zealand White rabbit. The method used followed the recommendations of the OECD Guidelines for Testing of Chemicals No. 404 “Acute Dermal Irritation/Corrosion” (adopted 17 July 1992) and Method B4 in Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC). A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produced very slight erythema. All treated skin sites appeared normal at the 24-hour observation. The test material produced a primary irritation index of 0.0 and was classified as a non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted. The test material did not meet the criteria for classification as irritant or corrosive according to OECD GHS labelling regulations. No symbol and risk phrase are required.
INDIVIDUAL & MEAN SCORES FOR CORNEA, IRIS & CONJUNCTIVAE REQUIRED FOR EC LABELLING REGULATIONS
Rabbit Number &Sex (Bodyweight kg)
Time After Treatment (hrs)
39 female (2.90)
15 female (2.76)
26 Male (2.96)
A study was performed to assess the irritancy potential of the test material, GBS-5, to the eye of the New Zealand White rabbit. The method used followed that described in the OECD Guidelines for Testing of Chemicals No. 405 “Acute Eye Irritation/Corrosion” (adopted 24 February 1987) and Method B5 in Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC). A single application of the test material to the non-irrigated eye of three rabbits produced minimal conjunctival irritation. All treated eyes appeared normal 48 hours after treatment. The test material did not meet the criteria for classification as irritant according to OECD-GHS labelling regulations. No symbol and risk phrase are required.
In two standard tests for skin and eye irritation in rabbits, GLDA-Na4 was not irritating. In the acute inhalation toxicity test in which rats were exposed to the technically highest attainable concentration, clinical signs of toxicity included slightly decreased breathing rate during exposure and sniffing in a few animals shortly after exposure up to 2 days after exposure. These signs point at very slight respiratory irritation only at a very high concentration.
Justification for selection of skin irritation / corrosion endpoint:
Well performed and reported study
Justification for selection of eye irritation endpoint:
No classification is needed for skin and eye irritation. Based on the clinical signs observed during the acute inhalation study, it was concluded that GLDA-Na4 does not need classification for respiratory irritation.
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