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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1992
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
- Name of test material (as cited in study report): SAT 960 405
- Physical state: amber-colourd, viscous liquid
- Lot/batch No.: 070596
- Expiration date of the lot/batch: 09/1997
- Storage condition of test material: room temperture, dark
- Impurities: nonyl phenol < 7%

Test animals

Species:
rabbit
Strain:
other: Mol:Russian
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Mollegaard Breeding and Research Centre A/S, Ejby, DK-4623 Lille Skensved
- Age at study initiation: no data
- Weight at study initiation: 2.0 - 2.5 kg
- Housing: individually
- Diet (e.g. ad libitum): rabbit diet "Altromin 2123" from Altromin; ad libitum
- Water (e.g. ad libitum): domestic quality drinking water acidified with hydrochloric acid to pH 2.5; ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23°C
- Humidity (%): 40 - 70%
- Air changes (per hr): 10 times / hour
- Photoperiod: 12 hrs dark / 12 hrs light

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
4h
Observation period:
21 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: two 16-layer gauze patches (2.5 x 2.5 cm)
- Type of wrap if used: Micropore tape, 5 cm width

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with lukewarm water
- Time after start of exposure: 4h

OBSERVATION TIME POINTS
1, 24, 48 and 72 hours after termination of exposure as well as 7, 14 and 21 days

SCORING SYSTEM:
- Method of calculation: The respective scores for erythema and oedema formation for the 3 readings 24, 48 and 72 hours of each rabbit were summed up separately and divided by 6. The results are the mean scores for erythema and oedema formation of the individual rabbit.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 21 days

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant)
Conclusions:
Based on the results of a study according to OECD Test Guideline 404 under GLP, the test substance is considered as skin irritating (applying the evaluation system of the EU regulation 1272/2008).
Executive summary:

The skin irritation potential of the test substance was evaluated in a study according to OECD Test Guideline 404 under GLP.

The amount of 0.5 ml of the substance was applied unchanged under semi-occlusive conditions for 4 hours to the clipped skin of three Mol:Russian rabbits, which were observed for 21 days post application. Over the first three days, clear erythema and oedema were observed in all rabbits, which reversed fully within 21 days.

Interpreting these results by applying the evaluation system of the EU regulation 1272/2008, the test substance is considered irritating to the skin.