Registration Dossier

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
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
data is from NTRL reports

Data source

Reference
Reference Type:
secondary source
Title:
REPORT OF THE INDUSTRIAL TOXICOLOGY SCREENING STUDIES IN RATS, MICE AND RABBITS
Author:
NTRL
Year:
1992
Bibliographic source:
NTRL report, 1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: BASF TEST and Draize test
Principles of method if other than guideline:
Primary dermal irritation study was performed in rabbits to assess the irritation potential of the test chemical
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
- Name of test material (as cited in study report):1,3,3-trimethyl-2-[3-(1,3,3-trimethyl-1,3-dihydro-2H-indol-2-ylidene)prop-1-en-1-yl]-3H-indolium acetate - Common Name: Basic Red 12 acetate- Molecular formula:C25H29N2C2H3O2- Molecular weight:416.562 g/mol- Substance type:Organic- Physical state:Solid

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS- Source: GAUKLER 6050 OFFENBACH/ maIN- Age at study initiation:no data- Weight at study initiation: rabbit 1- 3.68 kg, rabbit 2- 3.67 kg and rabbit 3- 2.97 kg- Fasting period before study:no data- Housing: stainless steel cages with GRADE GROUND FLAT 40 CM * 50 cm- Diet (e.g. ad libitum): STANDARDIET FOR RABBIT 4mm; FA. SSNIFF-VERSUCHSDIAETEN GmbH, ~ 770 SOEST (Approximately 130 G PER ANIMALS)- Water (e.g. ad libitum): approx 250ml per rabbit, water (monday - friday), tap water (saturday - sunday)- Acclimation period: no dataENVIRONMENTAL CONDITIONS- Temperature (°C): 20-26 deg C- Humidity (%):50- 80%- Air changes (per hr):no data- Photoperiod (hrs dark / hrs light): 12h/12 H (6.00 - 18.00 UHR/16.00 - 6.00 UHR)

Test system

Type of coverage:
occlusive
Preparation of test site:
other: intact and scarified skin
Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
0.5 ml undiluted sample
Duration of treatment / exposure:
4 hours
Observation period:
15-30 minutes after patch removal, then 48,72 hours till 8 days.
Number of animals:
3 (2 male and 1 female)
Details on study design:
Area of exposure: back of each rabbits% coverage: 2.5 cm * 2.5 cm patch- Type of wrap if used: occlusive wrapSCORING SYSTEM: Draize method

Results and discussion

In vitro

Other effects / acceptance of results:
no data available

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 8 day
Score:
3.9
Reversibility:
not specified
Remarks on result:
probability of moderate irritation
Irritant / corrosive response data:
Moderate to severe skin irritation along with tissue degeneration (necrosis) was noted in the rabbits.

Any other information on results incl. tables

Table: Skin irritation score

Animal no.

4 hours

Day 1

Day 2

Day 8

Redness

edema

Redness

edema

Redness

edema

Redness

edema

1

*

2

*

4 O

*

3O

*s

2

2

*

2

*

3

*

3O

*s

1

Redness : 1= questionable; 2= slightly; 3=strongly; 4=very strongly

Edema : 1= very slightly; 2=slightly; 3=strongly; 4=very strongly

 

O=Overlapping, S=scale formation

*=exact reading were not possible due to the coloring of skin

 

 

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
The observed primary irritation score after 8 days was ≥3.9Moderate to severe skin irritation along with tissue degeneration (necrosis) was noted in the rabbits.Based on the scores and observations,the test chemical was considered to be moderate to strongly irritatingto the rabbits’ skin.
Executive summary:

Primary dermal irritation study was performed in rabbits according to BASF TEST and Draize test methods to assess the irritation potential of the test chemical

3 (2 male and 1 female) albino Vienna White rabbits were used for the study.0.5 ml undiluted sample was applied to intact and scarified back skin of rabbits under occlusion. The untreated skin sites served as control. The occlusive patches were removed after 4 hours and the test sites. The sites were observed for signs of irritation15-30 minutes after patch removal, then 48, 72 hours till 8 days. The reactions were scored according to Draize method.

The observed primary irritation score after 8 days was ≥3.9

Moderate to severe skin irritation along with tissue degeneration (necrosis) was noted in the rabbits.

Based on the scores and observations,the test chemical was considered to be moderate to strongly irritatingto the rabbits’ skin.