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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

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Administrative data

skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
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 Type:
study report
Report date:

Materials and methods

Principles of method if other than guideline:
Skin irritation was tested using an internal method (BASF test)
GLP compliance:

Test material

Constituent 1
Reference substance name:
Reference substance 001
Details on test material:
no details

Test animals

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:
Preparation of test site:
not specified
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

Irritation parameter:
overall irritation score
animal #1
Time point:
24/48/72 h
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



48 h



72 h



6 days


No data

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

Applicant's summary and conclusion

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.