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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:
Jan/Feb 1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Guideline study. No GLP compliance is claimed, however, the final report includes an audit and quality assurance inspections. The skin preparation was not exactly performed in accordance to OECD Guideline 404. Furthermore, a 48h observation was not performed.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
The skin preparation was not exactly performed in accordance to OECD Guideline 404. The 48h observation was not performed.
Principles of method if other than guideline:
Detailed description of guideline deviations:
- Skin preparation: At 24 hours prior to study initiation, the fur on the back of each rabbit was clipped from an area approximately 240 cm2, and the skin was examined for abnormalities. On the day of treatment, four test sites (2.5 cm x 2.5 cm each), two on either side of the midline, were designated in the clipped area on the back of each rabbit. The test sites on the right side were abraded in a pattern with a hypodermic needle so as to penetrate the stratum corneum but not the dermis. The test sites on the left side were left intact. The results from the adraded test sites have been excluded from the calculation of the primary irritation index as the use of abraded skin does not follow current OECD test guidelines.
- Exposure: The application was for 24 h rather than the current OECD guideline exposure time of 4 h, and the 48h observation was not performed. Therefore, this represents a worst case.
GLP compliance:
no
Remarks:
Auditation and quality assurance inspections of the final report were performed.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
- Storage condition of test material: room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dutchland Laboratories, Denver, PA
- Weight at study initiation: 2.0 to 2.7 kg
- Fasting period before study: No
- Housing: Individually housed in stainless steel cages (61.0 x 45.5 x 42.0 cm)
- Diet: Rabbits were fed Purina Lab Rabbit Chow HF (Ralston Purina Co.) ad libitum
- Water: ad libitum
- Acclimation period: approx. 2 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): approx. 20
- Humidity (%): approx. 40 (relative)
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES:
1982-01-26 - 1982-02-09

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL applied to each test site
- Concentration: neat material used
Duration of treatment / exposure:
A 0.5 mL quantity of the test article was applied to each of the four test sites and covered with a 2.5 x 2.5 cm gauze pad which was secured by an adhesive dressing (CoverletR, Beiersdorf Inc., S. Norwalk. Conn.). The mid-section of the rabbit was wrapped in a lint-free cloth towel to prevent removal of the gauze pad while allowing the rabbit free movement. All wrapping materials and gauze pads were removed 24 hours after application and the test sites were washed with a 0.9 % sodium chloride solution to remove any residual test article.
Observation period:
The test sites were examined and scored 1, 3, 7 and 14 days after application for oedema, erythema, and eschar formation.
Each test site was scored for irritation according to the method of Draize.
Number of animals:
3 males and 3 females
Details on study design:
TEST SITE
- Area of exposure: 4 test sites (2.5 x 2.5 cm) on the back of each rabbit
- Type of wrap if used: Gauze pad was secured by an adhesive dressing (CoverletR, Beiersdorf Inc., S. Norwalk. Conn.). The mid-section of the rabbit was wrapped in a lint-free cloth towel to prevent removal of the gauze pad while allowing the rabbit free movement.

REMOVAL OF TEST SUBSTANCE
- Washing: 0.9 % sodium chloride solution
- Time after start of exposure: 24 h

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1 d
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: 12/12 test sites scored 2
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 3 d
Score:
1.8
Max. score:
2
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: 2/12 test sites scored 1; 10/12 test sites scored 2
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 7 d
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 14 d
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1 d
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 3 d
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 7 d
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 14 d
Score:
0
Max. score:
0
Irritant / corrosive response data:
No details available.
Other effects:
No other effects reported.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test report describes a valid guideline study, with auditation and quality assurance inspections of the final report. The test material is not considered to be a primary dermal irritant and does not require classification according to EU CLP.
Executive summary:

A dermal irritation study was conducted using a similar procedure to that described in the current OECD Guideline 404 (Reckers, 1982). The test material (CAS No. 91648-65-6) was applied at a dose of 0.5 mL to the backs of 3 male and 3 female rabbits (strain: New Zealand White). The test article was left in contact with the skin for 24 hours and then the test sites were washed with 0.9 % sodium chloride and the rabbits observed during this time and for 14 days after its removal. The test sites were scored at 1, 3, 7 and 14 days after removal. Erythema was observed in all rabbits at 1 and 3 days following application. Mean scores of 2 (after 1 day) and 1.8 (after 3 days) were reported. After 7 days any effects were fully reversed. Edema did not occur. All rabbits appeared normal 14 days after application. No rabbits died during the study.