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EC number: 201-121-3
CAS number: 78-50-2
No signs of systemic toxicity were observed
in any of the animals examined. No erythema was observed in any of the
animals examined except for the very slight erythema noted for both
animals treated at 25% and 50% on Day 6. Scaliness was noted for all
animals on Day 6. White staining of the dorsal surface of the ears by
test substance remnants was noted for both animals treated at 25% and
50% between Days 1 and 3. The staining did not hamper the scoring of the
ears. Thickened ears were noted for the animals treated at 25% between
Days 4 and 6.
Variations in ear thickness during the
observation period were less than 25% from Day 1 pre-dose values for the
animals treated at 5%, 10% and 25% but more than 25% from Day 1 pre-dose
values for the animals treated at 50%. Based on these results, the
highest test substance concentration selected for the main study was a
results - main study:
Skin reactions / Irritation:
No irritation of the ears was observed in
any of the animals examined. Scaliness was noted for all animals treated
at 10% and 25% on Day 6. Thickened ears were noted for all animals
treated at 10% and 25% on Day 6. White staining of the dorsal surface of
the ears by test substance remnants was noted for all animals treated at
25% on Days 1, 2 and 3. The staining did not hamper the scoring of the
Systemic toxicity/Body weights:
No mortality occurred and no clinical signs
of systemic toxicity were observed in the animals of the main study.
Body weights and body weight gain of experimental animals remained in
the same range as controls over the study period.
Macroscopy of the auricular lymph nodes and
All auricular lymph nodes of the animals of
the experimental groups were considered enlarged. No macroscopic
abnormalities of the surrounding area were noted for any of the animals.
A study was
conducted to assess the skin sensitizing potential of the test substance
in mouse (Local Lymph Node Assay), according to OECD Guideline 429, EU
method B42 and EPA, OPPTS 870.2600, in compliance with GLP. Test
substance concentrations selected for the main study were based on the
results of a pre-screen test. In the main study, three experimental
groups of five female CBA/J mice were treated at concentrations of 5, 10
or 25% w/w on three consecutive days, by open application on the ears.
Five vehicle control animals were similarly treated, but with vehicle
alone (methyl ethyl ketone). Three days after the last exposure, all
animals were injected with 3H-methyl thymidine and, after 5 h, the
draining (auricular) lymph nodes were excised and pooled for each
animal. After precipitating the DNA of the lymph node cells,
radioactivity measurements were performed. The activity was expressed as
the number of Disintegrations Per Minute (DPM) and a stimulation index
(SI) was subsequently calculated for each group. No irritation of the
ears was observed in any of the animals examined. Scaliness was noted
for all animals treated at 10 and 25% on Day 6. Thickened ears were
noted for all animals treated at 10 and 25% on Day 6. All auricular
lymph nodes of the animals of the experimental groups were considered
enlarged. No macroscopic abnormalities of the surrounding area were
noted for any of the animals. Mean DPM/animal values for the
experimental groups treated at 5, 10 and 25% were 3481, 6207 and 7069
DPM, respectively. The mean DPM/animal value for the vehicle control
group was 575. The SI values calculated for the substance concentrations
of 5, 10 and 25% were 6.1, 10.8 and 12.3, respectively. These results
show that the test substance elicits a SI ≥ 3. The data indicate a
dose-response and the EC3 value (the estimated test substance
concentration that will give a SI=3) was established to be between 0 and
5%. Under the study conditions, the test substance is a skin sensitiser
(Latour JEHM, 2015).
Based on the
results of a local lymph node assay, the test substance was found to be
sensitising under the experimental conditions. The results suggest a
classification as Skin
sensitizer, Category 1 - H317 (may cause an allergic skin reaction) according
to CLP (EC 1272/2008).
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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