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EC number: 229-355-1
CAS number: 6486-23-3
Acute toxicity of the test item has been investigated in female
SPF-Wistar rats (10 animals per dose group). The animals received 4000,
6300, 10000 or 15000 mg test item / kg bw by gavage (12.5% suspension in
sesame oil). The post observation period was 7 days. The mortality was
0/10, 1/10, 9/10 and 10/10 in the 4000, 6300, 10000 or 15000 mg / kg bw
dose group. The LD50 was calculated to be 8252 mg/kg bw. Animals which
died showed imbalance, accelerated respiration, prone position and
paralysis of the limbs. No pathologic findings were observed at necropsy.
The study used as
source investigated C.I. Pigment Yellow 1. The study results of the
source compound were considered applicable to the target compound and
were used for classification and labelling acc. to REGULATION (EC) No
1272/2008. Justification and applicability of the read-across approach
(structural analogue) is outlined in the read-across report in section
13 or find a link in cross reference “assessment report”.
Introduction. The study was performed to assess the acute dermal toxicity of the test item in the Wistar strain rat. The method was designed to be compatible with the following:
OECD Guidelines for the Testing of Chemicals No. 402 “Acute Dermal Toxicity” (adopted 24 February 1987)
Method B3 Acute Toxicity (Dermal) of CommissionRegulation (EC) No. 440/2008
A group of ten animals (five males and five females) was given a single, 24 hour, semi-occluded dermal application of the test item to intact skin at a dose level of 2000 mg/kg bodyweight. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.
There were no deaths.
There were no signs of systemic toxicity.
Very slight erythema was noted at the test site of one female. Crust formation and small superficial scattered scabs were also noted at this site. No other signs of dermal irritation were noted.
Animals showed expected gains in body weight over the study period except for one female which showed expected gain in body weight during the first week but slight body weight loss during the second week.
No abnormalities were noted at necropsy.
The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000 mg/kg body weight.
The study used as source investigated C.I. Pigment Yellow 1. The study results of the source compound were considered applicable to the target compound and were used for classification and labelling acc. to REGULATION (EC) No 1272/2008. Justification and applicability of the read-across approach (structural analogue) is outlined in the read-across report in section 13 or find a link in cross reference “assessment report”.
The test item and a close structural analogues did not cause adverse
effects after oral and dermal exposures.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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