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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:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report equivalent or similar to OECD guideline (404): GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar 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:
- Name of test material (as cited in study report): MRD-85-608
- Physical state: liquid

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): assumed 100% (neat)


Duration of treatment / exposure:
4 hours
Observation period:
45 minutes, 24, 48, and 72 hours and on day 7 post-patch removal
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: back
- % coverage:
- Type of wrap if used: semi-occlusive

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 h
Score:
1.3
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 h
Score:
1.5
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 h
Score:
1.5
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 h
Score:
0.5
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48 h
Score:
0.6
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 h
Score:
0.6
Reversibility:
not fully reversible within: 7 days
Irritant / corrosive response data:
Dermal exposure elicited very slight erythema in 4 animals and well-defined erythema in 2 animals at the 60 minute observation. Four animals displayed very slight edema at the 60 minute observation. Irritation increased slightly as the study progressed and at the 72 hour observation, two animals displayed well-defined erythema and one animal displayed moderate-to-severe erythema. Edema scores also increased and at the 72 hour observation two animals displayed very slight edema and one animal displayed slight edema. Irritation subsided slightly after the 72 hour observation and on day 7, two animals displayed very slight erythema and no edema, two animals displayed very slight erythema and very slight edema and one animal displayed well-defined erythema and very slight edema. Desquamation was noted in four of the six test animals at the day 7 observation period.

Applicant's summary and conclusion

Interpretation of results:
other: not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Slight irritation was noted, but subsided over a seven day observation period.
Executive summary:

In this study, 6 rabbits were exposed to CAS# 98072-31-2 via a semi-occlusive dermal patch for 4 hours.  Observations for skin irritation were made at 45 minutes, 24, 48, and 72 hours and on day 7 post-patch removal.  Dermal exposure elicited very slight erythema in 4 animals and well-defined erythema in 2 animals at the 60 minute observation.  Four animals displayed very slight edema at the 60 minute observation.  Irritation increased slightly as the study progressed and at the 72 hour observation, two animals displayed well-defined erythema and one animal displayed moderate-to-severe erythema.  Edema scores also increased and at the 72 hour observation two animals displayed very slight edema and one animal displayed slight edema.  Irritation subsided slightly after the 72 hour observation and on day 7, two animals displayed very slight erythema and no edema, two animals displayed very slight erythema and very slight edema and one animal displayed well-defined erythema and very slight edema.  Desquamation was noted in four of the six test animals at the day 7 observation period.