Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
June 05, 1975
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
The study has been conducted according to procedures similar to the accepted guidelines but the content of the active ingredient in the substance composition is very low.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report date:
1975

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO).
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Vat Red 013
IUPAC Name:
Vat Red 013
Test material form:
not specified

Test animals

Species:
rabbit
Strain:
not specified
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Russian breed
- Weight at study initiation: 1.5 to 2 kg
- Housing: animalshoused individually in metal cages
- Diet (e.g. ad libitum): ad libitum standard rabbit food - NAFAG, Gossau SG
- Water (e.g. ad libitum): ad libitum
- Acclimation period: for a minimum of 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 1 °C
- Humidity (%): 55 ± 5 %
- Photoperiod (hrs dark / hrs light): 14 hours light cycle day

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
not specified
Amount / concentration applied:
Not specified
Duration of treatment / exposure:
24 hours
Observation period:
after 24 and 72 hours
Number of animals:
3 males and 3 females
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm per side
- Type of wrap if used: gauze patch

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 hours

OBSERVATION TIME POINTS
24 and 72 hours

SCORING SYSTEM:
Score for skin irritation in rabbits

Erythema and eschar formation
No erythema 0
Very slight erythema (barely perceptible) 1
Well defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar
formation (injuries in depth) 4
Maximum possible erythema score 4

Edema formation
No edema 0
Very slight edema (barely perceptible) 1
Slight edema (edges of area well defined by
definite raising) 2
Moderate edema (raised approximately 1 mm) 3
Severe edema (raised more than 1 mm and
extending beyond area of exposure) 4
Maximum possible edema score 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0

Applicant's summary and conclusion

Interpretation of results:
other: CLP criteria not met
Conclusions:
Not skin irritant
Executive summary:

The substance was tested according to the Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO), on 3 male and 3 female rabbits.

Under test condition the substance resulted to be not irritant to skin.