Registration Dossier
Registration Dossier
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EC number: 451-520-3 | CAS number: -
Specific investigations: other studies
Administrative data
- Endpoint:
- specific investigations: other studies
- Adequacy of study:
- other information
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
Materials and methods
- Principles of method if other than guideline:
- Test procedure:
Test substance concentrations selected for the main study
were based on the results of a preliminary study.
In the main study, three groups of five experimental animals
were epidermally exposed to a 1%, 10% and 50% concentration
respectively on three consecutive days. Five vehicle
control animals were similarly treated, but with vehicle
alone (corn oil).
Three days after the last exposure, all animals were
injected with 3H-methyl thymidine and after five hours the
draining (auricular) lymph nodes were excised.
After precipitating the DNA of the lymph node cells,
radioactivity measurements were done.
Results and discussion
- Details on results:
- No irritation was observed in any of the animals examined.
The majority of nodes were equal in size, except for the
nodes of animals 2 (right node), 16 (left node) and 18 (both
nodes). No other macroscopic abnormalities of the nodes
were noted.
The slight body weight loss, noted in some animals, was not
considered toxicologically significant.
Mean DPM/animal values for the experimental groups treated
with test substance concentrations 1, 10 and 50% were 790,
559 and 358 respectively.
The mean DPM/animal value for the vehicle control group was
209.
No mortality occurred and no symptoms of systemic toxicity
were observed in the animals of the main study.
The SI values calculated for the substance concentrations
1%, 10% and 50% were 3.8, 2.7 and 1.7 respectively.
These data did not show a clear dose-response, however based
on the possibility of the lowest applied concentration to
elicit a SI > 3, it was considered that there is sufficient
evidence that the test substance has a sensitising potential
.No reliable EC3 value could be calculated
Applicant's summary and conclusion
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.
