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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1980
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: Hacking & Churchill ltd., Huntingdon, UK.
- Weight at study initiation: 2.9 kg.
- Accommodation: individual cages.
- Diet: ad libitum.
- Water: ad libitum.

ENVIRONMENTAL CONDITIONS
- Temperature: 19 - 25 °C.
- Humidity: 40 - 60 %.
- Photoperiod: 12 hours light and 12 hours dark.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
no
Amount / concentration applied:
0.5 g test substance.
Duration of treatment / exposure:
4 hours.
Observation period:
14 days.
Number of animals:
3 females.
Details on study design:
TEST SITE
- Area of exposure: ca. 2.5 × 2.5 cm.
- Type of wrap if used: gauze, secured with an elastic, air-permeable adhesive dressing.

REMOVAL OF TEST SUBSTANCE
- Washing: yes.
- Time after start of exposure: 4 hours.

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 eythema (beet redness) to slight eschar formation (injuries in depth)

Oedema formation:
0 no oedema
1 very slight oedema (barely perceptible)
2 slight oedema (edges of area well-defined by definite raising)
3 moderate oedema (raised approximately 1 mm)
4 severe oedema (raised more than 1 mm and extending beyond the area of exposure)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 3/3
Time point:
24/48/72 h
Score:
< 2.3
Remarks on result:
other: 14-d observation
Irritation parameter:
edema score
Basis:
animal: 3/3
Time point:
24/48/72 h
Score:
< 2.3
Remarks on result:
other: 14-d observation

Any other information on results incl. tables

animal no. 1h 24h 48h 72h 7d 14d
o. e. o. e. o. e. o. e. o. e. o. e.
1 0 0 0 0 0 0 0 0 0 0 0 0
2 0 0 0 0 0 0 0 0 0 0 0 0
3 - 0 0 0 0 0 0 0 0 0 0 0

o. = oedema

e. = erythema

Applicant's summary and conclusion

Interpretation of results:
other: not classified according to the CLP Regulation (EC 1272/2008)
Conclusions:
Under test conditions, the substance is not irritant to the rabbit skin.
Executive summary:

Method

Study in 3 female rabbits by semiocclusive application of test material under a composite patch on clipped skin. Upon a 4 -hour exposure to the test material, patches were removed and the skin was rinsed with water. Observation and scoring at 1h, 24 h, 48 h, 72 h, 7 d and 14 d after application were done based on the Draize scale (1940).

Result

Animals were observed for erythema and oedema. A score was associated to each animal, averaging over results at 24, 48 and 72 hours. None of the animals showed any observable response to treatment throughout the observation period.