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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
existing in-vivo study
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
limited report, non-GLP, test with formulation. limited information on results (no individual data, only 2 observations), The exposure during 24 hours represents a worst case. The information in the report is limited to the information in the summary.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: FHSLA, CFR Title 21, para. 191.11
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Bodyweight: 2.3 to 3.0 kg
No further details

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 40% in diluent oil

Duration of treatment / exposure:
24 hours
Observation period:
scored 24 and 72 hours after application
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm2
- Abrasions made over 2-3 cm2
- Type of wrap if used: plastic trunk band to prevent evaporation

REMOVAL OF TEST SUBSTANCE
- Washing (if done):none

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 and 72 h
Score:
ca. 3.66
Reversibility:
not reversible
Remarks on result:
other: score for non-abraded skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 and 72 h
Score:
ca. 0.16
Reversibility:
not reversible
Remarks on result:
other: score for non-abraded skin
Irritant / corrosive response data:
The results are presented for the abraded and non-abraded skin.
Other effects:
none reported

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The test material is irritating to the rabbit's skin.
Executive summary:

Six rabbits were exposed to the test material for 24 hours. Signs of irritation were observed (redness of the skin), which were not shown to be reversible. The test material is irritant.