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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
05.11. - 21.11.2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report date:
2004

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
3-amino-2-chlor-6-methylphenol
EC Number:
283-144-9
EC Name:
3-amino-2-chlor-6-methylphenol
Cas Number:
84540-50-1
Molecular formula:
C7H8ClNO
IUPAC Name:
3-amino-2-chloro-6-methylphenol
Test material form:
solid
Details on test material:
Colour: beige
Molecular weight: 157.5

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
3 males
Age: at least 6 weeks old
Body weight: at least 1.0 kg
Conditions:
Animals were housed in a controlled environment, in which optimal conditions were considered to be approximately 15 air changes per hour, a temperature of 21.0 ± 3.0°C (actual range: 19.5 - 22.1 °C), a relative humidity of 30-70% (actual range: 37 - 59%) and 12 hours artificial fluorescent light and 12 hours darkness per day.
Accommodation:
Individually in labelled cages with perforated floors (Scanbur, Denmark, dimensions 56x44x37.5 cm). Acclimatisation period was at least 5 days before start of treatment under laboratory conditions.
Diet:
Standard laboratory rabbit diet (Charles River Breeding and Maintenance Diet for Rabbits, Altromin, Lage, Germany) approx. 100 g. per day. Certificates of analysis were examined and retained in the NOTOX archives. In addition, pressed hay (BMI, Helmond, the Netherlands) was provided twice a week.
Water:
Free access to tap-water.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Amount / concentration applied:
0.5 g, the test substance was moistened with 0.7 ml Milli-U water
Duration of treatment / exposure:
4 hours
Number of animals:
3
Details on study design:
All available data relevant to the potential dermal irritation/corrosivity of the substance indicated that no severe effects were to be expected. An in-vitro test was considered, but a negative test result was anticipated that still would have to be confirmed in an in-vivo study. Since no severe harm for the animals was to be expected, this in-vivo skin irritation study was performed and was started by treatment of a single rabbit (sentinel). The two other animals were treated in a similar manner 13 days later, after considering the degree of skin irritation observed in the first animal.
Approximately 24 hours before treatment, the dorsal fur was clipped with electric clippers, exposing an area of approximately 150 square centimeters (10x15 cm2). Whenever considered necessary the treated skin areas were re-clipped at least 3 hours before the observations, to facilitate scoring.
A health inspection was performed prior to the commencement of treatment, to ensure that the animals were in a good state of health. Special attention was paid to the skin to be treated, which was intact and free from abnormalities.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 1 h
Score:
0
Max. score:
4
Remarks on result:
other: Yellowish staining of the skin by the test substance.
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 1 h
Score:
0
Max. score:
3
Remarks on result:
other: Yellowish staining of the skin by the test substance.
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
3
Irritation parameter:
edema score
Basis:
animal #1
Time point:
48 h
Score:
0
Max. score:
3
Irritation parameter:
edema score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
3
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 1 h
Score:
0
Max. score:
4
Remarks on result:
other: Yellowish staining of the skin by the test substance.
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
other: Yellowish staining of the skin by the test substance.
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
48 h
Score:
0
Max. score:
4
Remarks on result:
other: Yellowish staining of the skin by the test substance.
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 1 h
Score:
0
Max. score:
3
Remarks on result:
other: Yellowish staining of the skin by the test substance.
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24 h
Score:
0
Max. score:
3
Remarks on result:
other: Yellowish staining of the skin by the test substance.
Irritation parameter:
edema score
Basis:
animal #2
Time point:
48 h
Score:
0
Max. score:
3
Remarks on result:
other: Yellowish staining of the skin by the test substance.
Irritation parameter:
edema score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
3
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 1 h
Score:
0
Max. score:
4
Remarks on result:
other: Yellowish staining of the skin by the test substance.
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
other: Yellowish staining of the skin by the test substance.
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 1 h
Score:
0
Max. score:
3
Remarks on result:
other: Yellowish staining of the skin by the test substance.
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24 h
Score:
0
Max. score:
3
Remarks on result:
other: Yellowish staining of the skin by the test substance.
Irritation parameter:
edema score
Basis:
animal #3
Time point:
48 h
Score:
0
Max. score:
3
Irritation parameter:
edema score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
3
Irritant / corrosive response data:
Irritation
No skin irritation was caused by 4 hours exposure to A 094.

Corrosion
There was no evidence of a corrosive effect on the skin.
Other effects:
Colouration/Remnants
Yellowish staining of the treated skin by the test substance was observed during the observation period which did not hamper the scoring of the skin reactions.

Toxicity / Mortality
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Conclusions:
Based on these results and according to the:
- OECD Harmonized lntegrated Hazard Classification System for Human Health and Environmental Effects of Chemical Substances (OECD, 1998), A 094 / SAT 030633 does not have to be classified for skin irritation.
- EC criteria for classification and labelling requirements for dangerous substances and preparations (Council Directive 67/548/EEC), A 094 / SAT 030633 does not have to be classified and has no obligatory labelling requirement for skin irritation.
Executive summary:

Primary skin irritation/corrosion study with A 094 in the rabbit (4-hour semi­occlusive application).

The study was carried out based on the guidelines described in: OECD No.404, "Acute Dermal lrritation/Corrosion" (2002); EC Commission Directive 92/69/EEC, B.4, "Acute Taxicity - Skin irritation" (1992); US EPA, OPPTS 870.2500, Acute Dermal Irritation (1998) and JMAFF, Japanese Test Guidelines (2000).

Three rabbits were exposed to 0.5 grams of A 094, applied onto clipped skin for 4 hours using a semi-occlusive dressing. Observations were made 1, 24, 48 and 72 hours after exposure.

No skin irritation was caused by 4 hours exposure to A 094.

Yellowish staining of the treated skin by the test substance was observed during the observation period which did not hamper the scoring of

the skin reactions.

Based on these results and according to the:

- OECD Harmonized lntegrated Hazard Classification System for Human Health and Environmental Effects of Chemical Substances (OECD, 1998), A 094 / SAT 030633 does not have to be classified for skin irritation.

- EC criteria for classification and labelling requirements for dangerous substances and preparations (Council Directive 67/548/EEC), A 094 / SAT 030633 does not have to be classified and has no obligatory labelling requirement for skin irritation.