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Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1983-10-05 to 1983-11-30
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions. Only aggregate animal data was reported.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
Deviations:
not specified
GLP compliance:
yes

Test material

Constituent 1

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Ace Animals, Inc., Boyertown, PA, USA
- Age at study initiation: not stated
1 rabbit per cage, stainless steel with elevated wire mesh flooring.
temperature - 60 - 75 degrees F, 40 - 45% humidity, 12 hr ligh/dark photoperiod. Ad libitum Wayne 15% rabbit ration & tap water.
Rabbits acclimated prior to dosing

Test system

Type of coverage:
occlusive
Preparation of test site:
other: 2 sites/animal; 1 abraded and one intact
Vehicle:
other: skin moistened with deionised water
Controls:
no
Amount / concentration applied:
0.5 g, ground to powder.
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: Not stated
- Type of wrap if used: Gauze patch held with impervious material

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no, wiped only
- Time after start of exposure: 24 hours

SCORING SYSTEM: Draize

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: no effect observed
Irritant / corrosive response data:
No irritation response was recorded for either abraded or intact skin for any animal.
Other effects:
No effects observed

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material is not an irritant to the skin of rabbits. The test material is not classified in accordance with Regulation (EC) No. 1272/2008
Executive summary:

Test Guidance

In a study similar to US EPA OPP 81 -5 the test chemical was subjected to skin irritation testing. 0.5 g of the substance was applied to abraded and intact skin of 6 New Zealand White rabbits.

Results

No effects were noted at 24 hours on removal of the patches or at 72 hours after application of the test material.

Conclusion

The test material is not an irritant to the skin of rabbits. The test material is not classified in accordance with Regulation (EC) No. 1272/2008