Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions; deviations form guideline: occlusive dressing

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
occlusive dressing
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
occlusive
Preparation of test site:
abraded
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
4 hours
Observation period:
48 hours
Number of animals:
6 animals

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 30 min - 60 min
Score:
1.83
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 hours
Score:
1.17
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 hours
Reversibility:
no data
Remarks on result:
other: All animals showed dark discoloured and sclerotic skin at th treated sites so that they were killed for animal welfare reasons.

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Well defined erythema in 2/6 animals and very slight erythema in 4/6 animals after 24 hours. In 4/6 animals a very slight edema was observed after 24 hours. After 48 h at all test sites a dark discoloured, sclerotic skin was observed which did not allow any further evaluation. Therefore it was concluded that the test substance is corrosive.
Executive summary:

An acute dermal irritation/corrosion study according to OECD Guideline 404 was carried out with (Z)-2-(8-Heptadecenyl)-4,5-dihydro-1H-imidazole-1-ethanol in New Zealand White rabbits. After 48 h of treatment a dark discoloured, sclerotic skin was observed at all test sites which did not allow any further evaluation. Therefore it was concluded that the test substance is corrosive.