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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:
15 February to 12 April 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Primary Dermal Irritation Protocols (FIFRA, TSCA)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Appearance: Clear light yellow liquid
- Storage: room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: at least 8 weeks
- Housing: Animals individually housed in suspended stainless steel cages
- Diet: ad libitum
- Water: municipal water ad libitum
- Acclimation period: 56 days
- No known contaminants that were reasonably expected in food or water that would interfere with the study.
- Animals considered unsuitable were excluded from selection for the study

ENVIRONMENTAL CONDITIONS
- Temperature: 60-70 °F
- Relative humidity: 30-70 %
- Photoperiod: 12-h light/dark

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
The test material was administered as received (undiluted).
Duration of treatment / exposure:
4 hours
Observation period:
1 day (terminated in advance as a result of corrosive effect)
Number of animals:
3 animals per sex
Details on study design:
- Prior to exposure (~24 hours), the back of each rabbit was clipped, exposing the scapular-lumbar region.  
- Each animal was exposed to 0.5 mL of the test material via a treated 1 x 1 " gauze patch applied to the clipped area. 
- Patches were held in place with adhesive tape and gauze wrap for the 4-hour exposure period.  
- At the end of the exposure period, the gauze patches were removed and the skin reaction was observed every 30 minutes, for 24 hours.  
- Skin reactions were scored according to the Draize method.
- The most severely affected area was scored. Adjacent areas of untreated skin were used for comparison.
- Special notation was made of necrosis, eschar, or other evidence of irreversible alteration of tissue structure.
- Any abnormal pharmacologic or toxic signs were also noted.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
6 rabbits
Time point:
other: 30 minutes
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks:
due to accompanying necrosis in all 6 animals
Remarks on result:
other: One animal had eschar formation at the treatment site. All 6 animals sacrificed after the first observation time at 0.5 h after removal of treatment gauze.
Irritation parameter:
edema score
Basis:
mean
Remarks:
6 rabbits
Time point:
other: 30 minutes
Score:
1.17
Max. score:
4
Reversibility:
other: no data, animals were sacrificed
Remarks on result:
other: 2 rabbits with a score of 2, 3 rabbits with a score of 3, and 1 rabbit with a score of 0.
Irritant / corrosive response data:
At the first observation (i.e., 0.5 hours), all test animals exhibited severe erythema and either slight, very slight, or no oedema. Additionally, severe tissue destruction (i.e., necrosis, eschar, and lesions) was noted. Animals were sacrificed immediately for humane reasons. Under the conditions of the test, the test material was determined to be severely corrosive.

Applicant's summary and conclusion

Interpretation of results:
other: EU: Category 1
Conclusions:
Under the conditions of this study, the test material had a severe corrosive effect on rabbit skin exposed for 4 hours in an occlusive manner.
Executive summary:

Primary skin irritation tests were conducted in New Zealand White albino rabbits with the test material.

After exposure of the shaved skin to the undiluted test material for 4 hours under occlusive conditions, severe corrosive effects were observed at the first observation time point at 0.5 h after the treatment gauze was removed. All 6 animals had severe erythema accompanied by necrosis. One animal had eschar formation at the treatment site. The extent of oedema in the animals varied between no oedema (1 animal), very slight oedema (3 animals), and slight oedema (2 animals). All animals were sacrificed after the first observation due to humane reasons.

Under the conditions of this study, the test material had a severe corrosive effect on rabbit skin exposed for 4 hours in an occlusive manner.