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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:
1975-09
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Justification for type of information:
Justification for Read Across is given in Section 13 of IUCLID.

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
evalutation after 48 hours is missing; occlusive dressing; test substance was applied as a 50 % solution of which 1 ml/test site was used; exposure period of 24 hours
Qualifier:
according to
Guideline:
other: "Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: bred on the premises.
- Age at study initiation: 11 - 17 weeks.
- Weight at study initiation: 2.3 kg (males) and 2.98 kg (females).
- Housing: individually.
- Diet: commercial irradiated diet (Styles-Oxoid), ad libitum.
- Water: sterile filtered, ad libitum.
- Acclimation period: 1 week.

ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 1 °C.
- Humidity: 50 - 70 %.
- Photoperiod: 14 hrs dark / 10 hrs light.

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved with and without abrasion
Vehicle:
other: polyethylene glycol
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 1 ml/test site.
- Concentration (if solution): 50 % (w/v) in polyethylene glycol.
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
6 (3 males and 3 females)
Details on study design:
TEST SITE
- Area of exposure: back.
- % coverage: 10 % of the total body surface.
- Type of wrap if used: the test substance was applied to each test site on a 2.5 x 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" 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.

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 hours.

SCORING SYSTEM: Draize scoring system.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
other: mean over 24 and 72 hours
Score:
0.09
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: intact skin site
Irritation parameter:
edema score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
other: mean over 24 and 72 hours
Score:
0.6
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: intact skin site
Other effects:
None reported

Applicant's summary and conclusion

Interpretation of results:
other: not classified as skin irritant according to the CLP Regulation (EC) No.1272/2008
Conclusions:
The substance is not considered as a skin irritant to rabbits.
Executive summary:

The irritation potential of the test material to the skin of rabbits was assessed in a test similar/equivalent to the OECD Guideline 404. Three male and three female New Zealand white rabbits were dermally exposed to the substance diluted in polyethylene glycol. The back of the animals was shaved with and without abrsaion and the substance was applied in an occlusive coverage. After 24 hours of exposure the substance was removed and the animals were observed for 72 hours and scored for signs of erythema and edema.

The mean score (mean over 24 and 72 hours) was 0.09 and 0.6 at the intact skin for erythema and edema respectively. Both erythema and edema were reversible within 72 hours.

The substance is not considered as a skin irritant to rabbits.