Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
02-09-1997
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Reliability assessed according to Klimisch scores.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
The test material contains a slightly lower amount of C12 und C 14 epoxide than the registered substance.

Test animals

Species:
rabbit
Strain:
other: Mol:Russian
Details on test animals and environmental conditions:
according to guideline

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
undiluted
Duration of treatment / exposure:
according to guideline
Observation period:
21 days
Number of animals:
3
Details on study design:
according to guideline

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 hours mean
Score:
1.9
Max. score:
2
Reversibility:
fully reversible within: 21 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 hours mean
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 21 days
Irritant / corrosive response data:
The registered substance showed irritative properties which were fully reversible after 21 days.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance has to be classified as "irritating to the skin".
Executive summary:

The skin irritation potential of the test substance was evaluated in a study according to OECD Test Guideline 404 under GLP.

The undiluted test substance was applied unchanged under occlusive conditions for 4 hours to the shaved skin of three Mol:Russian rabbits, which were observed for 21 days post application. Over the first three days, clear erythema and oedema were observed in all rabbits, which reversed fully within 21 days.

Interpreting these results by applying the evaluation system of the EU regulation 1272/2008, the test substance is considered to be irritating to the skin. Since the composition of the registered substance is almost identical to the test substance, only the amount of C12 and C14 epoxide is slightly higher in the registered substance, this key study is taken as a valid read across for this endpoint and the registered substance is considered to be irritating to the skin accordingly.