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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:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report Date:
1974

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: U.S.A. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965)
Deviations:
not specified
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
(48 h observation not done; involved a 24 h test substance exposure followed by observations at 24 and 72 h; test substance was patched both on abraded and on intact skin of six animals; local and systemic adverse effects not described)
GLP compliance:
no
Remarks:
Pre-GLP study

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Specific details on test material used for the study:
Name: FAT 40075/A
Purity: 74.5 %

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Bred on the premises of the testing laboratory
- Age at study initiation: 3 to 4 months
- Weight at study initiation: Males: 2.33 kg; Females: 2.06 kg
- Housing: Caged singly
- Diet: A commercial irradiated diet (Styles-Oxoid), ad libitum
- Water: Sterile filtered water, ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 1 °C
- Humidity: 50-70 %
- Photoperiod: Animals were exposed to artificial light for 10 h daily from 08:00 - 18:00 h

Test system

Type of coverage:
occlusive
Preparation of test site:
other: both abraded and intact skin areas lateral to the midline of the back
Vehicle:
water
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.75 mL (i.e., 500 mg)
- Concentration (if solution): 66.66 %
Duration of treatment / exposure:
24 h
Observation period:
Up to 72 h (The skin reactions were assessed at 24 and 72 h)
Number of animals:
six animals (four males and two females)
Details on study design:
TEST SITE
- 24 h prior to the dermal application, the backs of the animals 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 animal. 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 site remained intact.
- The test substance was applied to each test site on a 2.5 cm² gauze pad. These were covered with aluminium foil secured with "Sleek" adhesive tape. The test sites were then enclosed by a 6 inch 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.

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
Intact skin
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
erythema score
Remarks:
Intact skin
Basis:
animal #1
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Remarks:
Intact skin
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Remarks:
Intact skin
Basis:
animal #2
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
erythema score
Remarks:
Intact skin
Basis:
animal #2
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Remarks:
Intact skin
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Remarks:
Intact skin
Basis:
animal #3
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
erythema score
Remarks:
Intact skin
Basis:
animal #3
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Remarks:
Intact skin
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Remarks:
Intact skin
Basis:
animal #4
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Remarks:
Intact skin
Basis:
animal #4
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Remarks:
Intact skin
Basis:
animal #4
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Remarks:
Intact skin
Basis:
animal #5
Time point:
24 h
Score:
1
Max. score:
4
Irritation parameter:
erythema score
Remarks:
Intact skin
Basis:
animal #5
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Remarks:
Intact skin
Basis:
animal #5
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Remarks:
Intact skin
Basis:
animal #6
Time point:
24 h
Score:
1
Max. score:
4
Irritation parameter:
erythema score
Remarks:
Intact skin
Basis:
animal #6
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Remarks:
Intact skin
Basis:
animal #6
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Remarks:
Intact skin
Basis:
animal #1
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
edema score
Remarks:
Intact skin
Basis:
animal #1
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Remarks:
Intact skin
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Remarks:
Intact skin
Basis:
animal #2
Time point:
24 h
Score:
4
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
edema score
Remarks:
Intact skin
Basis:
animal #2
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Remarks:
Intact skin
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Remarks:
Intact skin
Basis:
animal #3
Time point:
24 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
edema score
Remarks:
Intact skin
Basis:
animal #3
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Remarks:
Intact skin
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Remarks:
Intact skin
Basis:
animal #4
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
edema score
Remarks:
Intact skin
Basis:
animal #4
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Remarks:
Intact skin
Basis:
animal #4
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Remarks:
Intact skin
Basis:
animal #5
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
edema score
Remarks:
Intact skin
Basis:
animal #5
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Remarks:
Intact skin
Basis:
animal #5
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Remarks:
Intact skin
Basis:
animal #6
Time point:
24 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
edema score
Remarks:
Intact skin
Basis:
animal #6
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Remarks:
Intact skin
Basis:
animal #6
Time point:
72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
A slight erythema and a slight to severe oedema was seen in all animals involving both intact and abraded sites 24 h after application of the test substance. By 72 h a slight to mild oedema was seen in the abraded sites of 3/6 animals.

Any other information on results incl. tables

Table:

Erythema Formation

Total

Intact

Abraded

Animal no./sex

24 h

72 h

24 h

72 h

 

1 (Male)

1

0

1

0

2 (Male)

1

0

1

0

3 (Male)

1

0

1

0

4 (Female)

0

0

1

0

5 (Female)

1

0

1

0

6 (Female)

1

0

1

0

Mean

0.83

0.00

1.00

0.00

1.83

Oedema Formation

Total

Intact

Abraded

No. animal

24 h

72 h

24 h

72 h

 

1 (Male)

2

0

2

0

2 (Male)

4

0

4

2

3 (Male)

3

0

3

0

4 (Female)

1

0

2

2

5 (Female)

2

0

2

0

6 (Female)

3

0

3

1

Mean

2.50

0.00

2.67

0.83

6.00

 

Erythema + Oedema

7.83

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the study conditions, the test substance was considered to be non-irritating to skin.
Executive summary:

An in vivo study was conducted to evaluate the skin irritation potential of the test substance (at ca. 74.5 % purity) in rabbits according to the US-FHSA Sect. 191.11 (February 1965) method which is similar to OECD Guideline 404 with few deviations. The test substance was applied under two patches (each on an intact and an abraded site) on the backs of six animals (3/sex). Each test site received 0.75 mL (i.e. 500 mg) of 66.66 % solution in water on a 2.5 cm² gauze pad for 24 h under occlusive conditions. Resulting skin lesions were assessed for erythema and oedema at 24 and 72 h after patch removal. Slight erythema and slight to severe oedema was seen in all animals involving both intact and abraded sites 24 h after application of the test substance. By 72 h, a slight to mild oedema was seen in the abraded sites of 3/6 animals. Skin reactions of intact test sites (by 72 h) returned to normal earlier than abraded. Under the study conditions, the test substance was considered to be non-irritating to skin.