2,2-dimethylpropane-1,3-diol

Skin irritation / corrosion

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

Test material information

Constituent 1

Reference substance name:

Reference substance 001

Details on test material:

no details

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system 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.