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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:
July 28, 1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
The test was conducted by means of Read Across approach. 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:
no
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

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: average body weights of 2.73 kg (males) and 2.38 kg (females)
- Housing:The rabbits were caged singly in an experimental room.
- Diet (e.g. ad libitum): a commercial irradiated diet (Styles-Oxoid) was fed ad libitum.
- Water (e.g. ad libitum): sterile filtered water was available at all times.
- Acclimation period: six rabbits were acclimatized in the test area for one week prior to the start of the trial.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 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:
semiocclusive
Preparation of test site:
abraded
Vehicle:
water
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 g of the test compound was mixed with 12 ml of water to make a solution of 15ml 0.75 ml of which was applied to each test- site on a 2.5 cm square gauze pad.
Duration of treatment / exposure:
24 hours
Observation period:
24 hours and 72 hours
Number of animals:
Six rabbits ( 3 male and 3 female)
Details on study design:
TEST SITE
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 mid line of the back were used on each rabbit. Immediately before the application of the test compound, the right hand site was abraded with the point of a sterile hypodermic needle. The abrasions were sufficiently deep to penetrate the stratum corneum but not to damage the dermis. The left hand sits remained intact.

These were covered with aluminum foil secured with "Sleek"* adhesive tape. The test sites were then enclosed by a 6" wide "Cobon” 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.

SCORING SYSTEM:
Primary irritation score Rating
0 Non irritating
0.1 - 0.5 Minimally irritating
0.6 - 1.5 Slightly irritating
1.6 - 3.0 Mildly irritating
3.1 - 5.0 Moderately irritating
5.1 - 6.5 Severely irritating
6.6 - 8.0 Extremely irritating

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 11, 12, 13, 15, 16
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no symptoms
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
animal: 14
Time point:
24/48/72 h
Score:
ca. 0.66
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal: 11, 15, 16
Time point:
24/48/72 h
Score:
ca. 1.66
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal: 12
Time point:
24/48/72 h
Score:
ca. 0.66
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal: 13
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Reversibility:
other: no symptoms
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal: 14
Time point:
24/48/72 h
Score:
ca. 2.66
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: intact skin

Any other information on results incl. tables

Erythema Formation:

No./Sex Intact Abraded Total
24 hrs 72 hrs 24 hrs 72 hrs
11 0 0 0 0  
13 0 0 0 0
15 0 0 0 0
12 0 0 1 0
14 1 0 1 0
16 0 0 0 0
Mean 0.17 0 0.33 0 0.5

Oedema Formation

No./Sex Intact Abraded Total
24 hrs 72 hrs 24 hrs 72 hrs
11 2 0 3 0  
13 0 0 1 0
15 2 0 2 0
12 1 0 1 0
14 3 0 2 0
16 2 0 1 0
Mean 1.67 0 1.67 0 3.33

Total Erythema + Oedema Score = 3.83

Applicant's summary and conclusion

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

Method

The skin irritation potential of the test substance was determined according to the method given in the "Hazardous Substances Regulations" under the U.S. Federal Hazardous. Substances Labelling Act Sect. 191.11 (February 1965).

 

Observations

Slight erythema and very slight to moderate edema was seen on 2/6 and 6/6 rabbits respectively, 24 hours after application of the compound. All sites were normal by 72 hours.

There was no marked difference in the reactions between abraded and intact sites.

 

Conclusion

Not irritant