Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given: scientifically acceptable study report

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Principles of method if other than guideline:
BASF test
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Gaukler, 6050 Offenbach, Germany
- Weight at study initiation: approx. 3.1 kg (mean)
- Sex: male / female
- Diet (ad libitum): Ssniff-K-standard diet/rabbit Intermast, Soest
- Water (ad libitum): tap water

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin sites of the same animals
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): undiluted, no amount specified
Duration of treatment / exposure:
1 min, 5 min, 15 min, and 20 h
Observation period:
8 days
Number of animals:
2
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: patch, no further data


REMOVAL OF TEST SUBSTANCE
- Washing: yes (exposure 1, 5, 15 min) first with undiluted Lutrol 9, then with an aqueous Lutrol solution (50 %); no (exposure 20 h)
- Time after start of exposure: 1, 5, and 15 min, respectively


SCORING SYSTEM:
The original BASF grading was converted into the numerical grading according to the OECD Draize system.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
15 min exposure
Basis:
mean
Remarks:
(2 animals)
Time point:
other: 24-48-72 h
Score:
3.9
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
edema score
Remarks:
15 min exposure
Basis:
mean
Remarks:
(2 animals)
Time point:
other: 24-48-72 h
Score:
2.9
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
erythema score
Remarks:
20 h exposure
Basis:
mean
Remarks:
(2 animals)
Time point:
other: 24-48-72 h
Score:
3.9
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: 1st Trial
Irritation parameter:
edema score
Remarks:
20 h exposure
Basis:
mean
Remarks:
(2 animals)
Time point:
other: 24-48-72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: 1st Trial
Irritant / corrosive response data:
Twenty four hours following the 1-, 5- and 15-minute applications strong erythema and edema were seen. The 20-hour exposure (trial 1) caused slight necrosis in addition to erythema and edema. Six and eight days after the applications, slight scaling was observed for the 1-, 5- and 15 -minute applications. The 20-hour application (trial 1) caused parchment like necrosis of the upper skin layer and scaling. The trial 2 of 20 h application resulted into similar responses as observed in trial 1.

Any other information on results incl. tables

                                            Skin Irritation Score, Rabbit 1/2, Erythema

Exposure time

24 h

48 h

72 h

Mean

1 min

4a/3a

4a/3a

1/0

3/2

5 min

4a/4a

4a/4a

2a/4

3.3/4

15 min

4a/4a

4/4a

3a/4

3.7/4

20 h (trial 1)

4a/3a

4b/4b

4b/4b

4/3.7

Skin Irritation Score, Rabbit 1/2, Edema

Exposure time

24 h

48 h

72 h

Mean

1 min

3a/3a

3a/3a

0/3

2/3

5 min

3a/3a

3/3a

2a/2

2.7/2.7

15 min

3a/3a

3/3a

3a/2

3/2.7

20 h (trial 1)

3/3

3/3

3/3

3/3

a- extending beyond the area of application

b- livid

Applicant's summary and conclusion