Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 214-688-7 | CAS number: 1185-81-5
Endpoint summary
Administrative data
Description of key information
Oral:
A study was conducted to determine the potential for oral toxicity using the Acute Toxic Class Determination. This study is designed to comply with the standards set forth in OECD Guidelines for the Testing of Chemicals, Guideline 423 adopted December 17, 2001. Guideline 423 is referred to in OPPTS 870,1000 (December 2002) as an acceptable method to assess lethality within a dose range.
The LD50 is greater than 2000 mg/kg of body weight in rats.
Dermal:
The study was conducted to determine the potential for toxicity of the test article when applied dermally and was designed to comply with the standards set forth in OECD Guidelines for Testing Chemicals, Number 402, adopted February 24, 1987.
The dermal LD50 of the test material is greater than 1000 mg/kg but less than 2000 mg/kg of body weight.
Key value for chemical safety assessment
Additional information
Oral:
Key Value : The LD50 was determined to be >2000 mg/kg.
- The key study (Yasso, 2010) was performed to assess the acute oral toxicity of the test material in the Sprague Dawley rat. The method was designed to comply with the standards set forth in OECD Guidelines for the Testing of Chemicals, Guideline 423 adopted December 17, 2001. Guideline 423 is referred to in OPPTS 870,1000 (December 2002) as an acceptable method to assess lethality within a dose range.
A reliability score of 1 was assigned according to Klimisch, 1997 as the study was conducted to recognised guidelines and GLP.
The following supporting study is also available:
- In a study conducted at Industrial Bio-Test Laboratories, 1977, Albino rats from Charles river; Strain Crl: COBS were given the test material as a 5.0 percent (w/v) corn oil solution at 30, 100 and 300 mg/kg and undiluted at 1,000, 3000 and 10,000 mg/kg.
Hypoactivity, Hemorrhagic salivation, Diuresis, Ruffed fur, Alopecia (face, limbs, caudal region) and Hyperirritability were seen at the highest dose level (10000 mg/kg). No effects were seen at any other dose level.
No animals died during the study and so the LD50 was considered to be >10,000 mg/kg.
A reliability score of 3 was assigned according to Klimisch, 1997 due to severe deviations; only 1 animal was used per dose.
Dermal:
Key Value : The LD50 was determined to be >1000 but <2000 mg/kg.
- The key study (DiDonato, 2010) was performed to assess the acute dermal toxicity of the test material in female New Zealand White rabbits. The method was designed to comply with the standards set forth in OECD Guidelines for Testing Chemicals, Number 402, adopted February 24, 1987.
A reliability score of 1 was assigned according to Klimisch, 1997 as the study was conducted to recognised guidelines and GLP.
- In a supporting study conducted at Industrial Bio-Test Laboratories, 1977, New Zealand White rabbits had the test material applied undiluted to approximately 30% of thier body surface area at 200, 500 and 2000 mg/kg.
The animal tested at the highest dose died. Symtoms included Diarrhea, weight loss and skin irritation.
It was not possible to determine the LD50 due to the lack of animals tested per dose, however the animal tested at 500 mg/kg survived and the animal tested at 2000 mg/kg died. With this in mind the LD50 is thought to lie somwhere between 500 and 2000 mg/kg.
A reliability score of 3 was assigned according to Klimisch, 1997 due to severe deviations; only 1 animal was used per dose, skin was abraded and an occlusive dressing was used.
Justification for classification or non-classification
Oral
The key parameter chosen for acute toxicity for the oral route was greater than the criteria set out in Directive 67/548/EEC and also Regulation (EC) no 1272/2008, therefore classification for acute toxicity was not considered to be necessary.
Dermal
The LD50 value for acute dermal toxicity was determined to lie somewhere between 1000 and 2000 mg/kg. The classification triggered under 67/548/EEC and EC Regulation 1272/2008 are presented as follows:
- 67/548/EEC: Xn; R21 - Harmful in contact with skin.
- EC Regulation 1272/2008: Acute toxicity: Dermal, Category 4; H312: Harmful in contact with skin.
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.
