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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:
1972
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1972
Report Date:
1972

Materials and methods

Principles of method if other than guideline:
Test substance at three dose levels was applied to the clipped intact and abraded skin on the back of 12 albino rabbits (4/dose) under occlusive conditions for 24 hours, and the skin reactions were scored.
GLP compliance:
no
Remarks:
pre-GLP

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Label on test material: RIFM 71-10-56 1-13-72

Test animals

Species:
rabbit
Strain:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2-3 kg
- Housing: Individually housed in metabolism cages
- Diet (e.g. ad libitum): Rabbit pellets, ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least 2 weeks

Test system

Type of coverage:
occlusive
Preparation of test site:
abraded
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.0, 3.9 and 6.0 mL/kg bw
- Concentration (if solution): Undiluted
Duration of treatment / exposure:
24 hours
Observation period:
14 days
Number of animals:
12 rabbits (4/dose)
Details on study design:
TEST SITE
- Area of exposure: Prior to placing the animals on test their backs were clipped free of all hair with small animal clippers. The backs were further prepared by making epidermal abrasions every two to three centimeters, longitudinally, over the clipped area of exposure. The abrasions were sufficiently deep so that they penetrated the stratum corneum bot not the dermis, so that no bleeding occurred.
- Type of wrap if used: Application areas were covered with a rubber sleeve or dam which fit snuggly around each animal.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Application sites were thoroughly wiped down.
- Time after start of exposure: 24 hours

OBSERVATION TIME POINTS: 24 hours after application and throughout the 14 days observation period

Results and discussion

In vivo

Results
Irritation parameter:
other: observation of signs of irritation
Remarks on result:
no indication of irritation
Remarks:
at the end of 24-hour contact period and throughout the 14 days observation period
Irritant / corrosive response data:
Application sites on the back of rabbits did not show any erythema or oedema at the end of 24-hour contact period and remained normal throughout the study.
Other effects:
All animals consumed their daily ration, gained weight and behaved as normal laboratory acclimatized animals. A comparison of the initial and final haematogram values of each animal did not reveal any significant changes.

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In accordance with Regulation EC No 1272/2008, the test substance does not require classification for skin irritation according to CLP and GHS regulations. No hazard statement and no signal word were required.
Executive summary:

Test substance at the dose levels of 2.0, 3.9 or 6.0 mL/kg bw was applied to the clipped intact and abraded skin on the back of 12 albino rabbits (4/dose) under occlusive conditions for 24 hours. Following the 24-hour exposure period, patches were removed and skin reactions were recorded. Animals were also observed for food consumption, body weights and general behaviour for 14 days.

Application sites on the back of rabbits did not show any erythema or oedema at the end of 24-hour contact period and remained normal throughout the study. All animals consumed their daily ration, gained weight and behaved as normal laboratory acclimatized animals. A comparison of the initial and final haematogram values of each animal did not reveal any significant changes.

In accordance with CLP (Regulation EC No 1272/2008) and GHS regulations, the test substance was identified as not requiring classification for skin irritation. No hazard statement and no signal word are required.