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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:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study meets scientific standards with exceptable restrictions (limited documentation, e.g. no details about test substance or applied amount of test substance)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1966
Report Date:
1966

Materials and methods

Principles of method if other than guideline:
Skin irritation was tested using an internal method (BASF test)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
no details

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
no details except initial body weight: rabbit 1 2.44 kg (female) and rabbit 2 3.63 kg (female)

Test system

Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
water
Controls:
no
Amount / concentration applied:
An application site of 2.5 X 2.5 cm was covered with the liquid; suspension (80% test substance in water) applied to the skin; no further data
Duration of treatment / exposure:
Experiment 1: 1, 5, or 15 minutes
Experiment 2: 20 h
Observation period:
Experiment 1: up to 48 h
Experiment 2: up to 7 days
Number of animals:
2 rabbits each in experiment 1 & 2
Details on study design:
After the exposure time, the skin was washed with 50% Lutrol in water.

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Experiment 1
No skin irritation detected in any rabbit at the day of application (no further details) or 24 and 48 h after administration.
Experiment 2
see Table below

Any other information on results incl. tables

Experiment 2: Skin irritation in 2 rabbits after dermal exposure to the 80% suspension in water for 20 h followed by washing with 50% Lutrol

Time after initiation of exposure

Irritation in

Rabbit 1

Rabbit 2

24 h

±

Ø

48 h

±

Ø

72 h

±

Ø

6 days

Ø

No data

  ±: hint/trace of irritant effect (questionable) corresponding to Draize score 1

Applicant's summary and conclusion

Conclusions:
The test substance has no skin irritant properties.
Executive summary:

The study meets scientific standards with exceptable restrictions (limited documentation, e.g. no details about test substance or applied amount of test substance) and is a worst case scenario in comparison to OECD Guideline 404 (4 h exposure, semiocclusive).

Two rabbits were dermally exposed to a suspension (80% in water) for 20 h. The coverage was occlusive; the skin was washed. Skin reaction was scored 24, 48 & 72 h (rabbit 1&2) and 6 days (rabbit 1) after initiation of exposure. In one rabbit questionable effects were found 24, 48 and 72 h after initiation but no effects at day 6 (rabbit 1); no irritation was detected in rabbit 2 at any time interval.

Conclusion: The test substance has no skin irritant properties.