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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)
Remarks:
Test substance is one component of the target (UVCB) substance; it is one of the major components, ranging between 10 - 60 % w/w. Other components show slight differences in terms of position / type of functional groups.
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
Source study has reliability 2. Details on the read across are available in section 13.

Data source

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

Materials and methods

Principles of method if other than guideline:
Patch-test technique described in the "Appraisal of the safety of chemicals in foods, drugs and cosmetics" of the US Association of Food and Drug Officials (AFDO), 1959.
Compared to the currently accepted OECD guideline 404: duration was 24 h instead of 4 h; no rinse was done; application was also on scarified skin; no 48 h observation was done.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
other: Russian
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1.5 to 2 kg
- Housing: singly, in V2A wire cages
- Diet: ad libitum
- Water: ad libitum

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Remarks:
intact and scarified
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
24 h
Observation period:
72 h
Number of animals:
3 male / 3 female rabbits
Details on study design:
TEST SITE
- Area of exposure: 2.5 × 2.5 cm gauze patch
- Type of wrap if used: 5 × 5 cm plastic film

OBSERVATION TIME POINTS
24 and 72 h after application.

SCORING SYSTEM:
Erythema and eschar formation
0 no erythema
1 very slight erythema (barely perceptible)
2 well defined erythema
3 moderate to severe erythema
4 severe erythema (beet redness) to slight eschar formation (injuries in depth)

Edema Formation
0 no edema
1 very slight edema (barely perceptible)
2 slight edema (edges of area well defined by definite raising
3 moderate edema (raised approximately 1 mm)
4 severe edema (raised more than 1 mm and extending beyond area of exposure)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation

Any other information on results incl. tables

No signs of irritation were noted on both intact and scarified skin.

Applicant's summary and conclusion

Interpretation of results:
other: not irritant according to the CLP Regulation (EC 1272/2008)
Conclusions:
Not irritant to skin of rabbits.
Executive summary:

Method

Skin irritation potential of test substance was assessed by application of 0.5 g under gauze patches to both intact and scarified skin of 6 rabbits. Gauze patches were removed 24 h after application; skin reaction was scored 24 h (upon removal) and 72 h after application.

Results

No signs of skin irritation in terms of oedema and erythema were noted.