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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Automatically generated during migration to IUCLID 6, no data available
IUPAC Name:
Automatically generated during migration to IUCLID 6, no data available
Details on test material:
CPMK >99% colurless liquid

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
24 hours
Number of animals:
3
Details on study design:
One the day of the test a suitable test site was selected on the back of each rabbit. A quantity of 0.5ml of the test material was introduced under a 25 ×25mm cotton gauze patch and placed in position on the shorn skin. The patch was secured in position with a strip of surgical adhesive tape (BLENDERM: approximate size 25×40mm). The trunk of each rabbit was wrapped in an elasticated corset (TUBIGRIP). Four hours after application the corset and patches were removed from each animal and any residual test material removed by gentle swabbing with cotton wool soaked in distilled water. The test sites were examined for evidence of primary irritation and scored according to the Draize method.

Results and discussion

In vivo

Irritant / corrosive response data:
Erythema: Score 4 for all animals
Edema: Score 4 for 2 animals. Score 2 for 1 animal
Other effects:
One animal was found dead 17 and a half hour after patch removal.

Any other information on results incl. tables

Severe erythema, slight to severe oedema and green-coloured dermal necrosis were noted at all treated skin sites one hour after patch removal. Haemorrhage of the dermal capillaries was also noted at two treated skin sites at this time. Hardened dark brown/black-coloured scab, preventing accurate evaluation of erythema and oedema was noted at two treated skin sites at the 24-hour observation. Haemorrhage of the dermal capillaries was also noted at one treated skin site at this time. Signs of systemic toxicity noted in one animal at the 24-hour observation were ataxia diarrhoea, hunched posture, lethargy and laboured respiration.

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information
Conclusions:
The test material, CPMK was classified as Corrosive to rabbit skin. Corrosive effects were noted in all rabbits. The symbol "C" and risk phase R34 "Causes burns" are required.