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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
June 02, 1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
The endpoint was evaluated by means of Read Across approach. THe complete justification is attached at section 13. The reliability of the source study report is 2. Further information was attached at section 13

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: "Hazardous Substances Regulations" under the U.S. Federal Hazardous . Substances Labelling Act Sect. 191.11 (February 1965).
Deviations:
not specified
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS

- Age at study initiation: 10 - 13 weeks
- Weight at study initiation: 2.90 Kgs. (♂) and 2.21 Kgs. (♀)
- Housing: semi-barrier system.
- Diet: A commercial irradiated diet (Styles-Oxbid) was fed ad libitum.
- Water: Sterile filtered water was available at all times.
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C. (± 1°)
- Humidity (%):50-70%
- Photoperiod (hrs dark / hrs light): Animals were exposed to artificial light for 10 hours daily from 08.00 - 18.00 hours.

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved and abraded
Vehicle:
water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Concentration (if solution):10g. of the test compound was mixed with 10ml. of water to make a solution of 15ml. 0.75ml. of which was applied to each test site
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
4 males and 2 females
Details on study design:
TEST SITE
- Area of exposure: the backs of the rabbits were shaved over an area consisting of at least 10% of the total body surface. Two test sites lateral to the mid line of the back were used on each rabbit. Immediately before the application of the test compound, the right hand site was abraded
- Type of wrap if used: The area were covered with aluminium foil secured with "Sleek" adhesive tape. The test sites were then enclosed by a 6" wide "Coban" self adhesive bandage the edges of which were fixed to the skin by strips of "Sleek" in order to retain the test substance in close contact with the skin.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 11
Time point:
other: 24, 72 hours
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal: 13
Time point:
other: 24, 72 hours
Score:
ca. 0.66
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal: 15
Time point:
other: 24, 72 hours
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal: 12
Time point:
other: 24, 72 hours
Score:
ca. 0.66
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal: 14
Time point:
other: 24, 72 hours
Score:
ca. 0.66
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal: 16
Time point:
other: 24, 72 hours
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal: 11
Time point:
other: 24, 72 hours
Score:
ca. 0.66
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal: 13
Time point:
other: 24, 72 hours
Score:
ca. 1.33
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal: 15
Time point:
other: 24, 72 hours
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal: 12
Time point:
other: 24, 72 hours
Score:
ca. 1.33
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal: 14
Time point:
other: 24, 72 hours
Score:
ca. 0.66
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal: 16
Time point:
other: 24, 72 hours
Score:
ca. 1.33
Max. score:
4
Reversibility:
fully reversible

Applicant's summary and conclusion

Interpretation of results:
other: CLP criteria not met
Conclusions:
Not irritant.
Executive summary:

Method

The substance was tested for skin rabbit according to the "Hazardous Substances Regulations" under the U.S. Federal Hazardous .Substances Labelling Act Sect. 191.11 (February 1965). Twenty-four hours prior to the dermal application, the backs of the rabbits were shaved over an area consisting of at least 10 % of the total body surface. Two test sites lateral to the midline of the back were used on each rabbit. The left hand site remained intact.

Results

Slight erythema and very slight to slight oedema were seen in 4/6 and 5/6 rabbits respectively 24 hours after application of the compound. All sites were normal by 72 hours.

Conclusion

Non irritant