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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
June - October 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
1,2-dichloro-4-(trichloromethyl)benzene
EC Number:
235-869-7
EC Name:
1,2-dichloro-4-(trichloromethyl)benzene
Cas Number:
13014-24-9
Molecular formula:
C7H3Cl5
IUPAC Name:
1,2-dichloro-4-(trichloromethyl)benzene
Details on test material:
- Name of test material (as cited in study report): 3, 4- Dichlorbenzotrichlorid (Intermediate of SLA 3992)
- Physical state: colorless liquid
- Analytical purity: 98.6-99.3 %
- Lot/batch No.: 16001/89
- Stability under test conditions: guaranteed for the study period
- Storage condition of test material: room temperature, in the dark.
-pH: 3.8 (2% in 0.9% NaCl-solution)

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Interfauna U.K. Ltd, England
- Age at study initiation: adult
- Housing: individually caged in stainless steel cages, in one room
- Diet: standard diet "Ssniff k4", approx 100-120 g per animal and day
- Water : drinking tap water
- Acclimation period: at least 14 days before the test start

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3 °C
- Humidity (%): approx 50%
- Air changes (per hr): approx 10
- Photoperiod (hrs dark / hrs light): 12 hours artificial illumination

IN-LIFE DATES: From: June 20 1989 To: October 03, 1989

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
other: the contralateral skin area not treated served as control.
Amount / concentration applied:
500 µL of the test substance
Duration of treatment / exposure:
4 hours
Observation period:
24, 48 and 72 h after application and on day 7 and day 14
Number of animals:
6
Details on study design:
Approximately 24 hours before the test, fur was removed by clipping from the dorso-lateral area of the trunk (6 x6 cm) of each six rabbits. 500 µL of the test substance was applied to a hypoallergenic Hansamed patch. A further patch was moistened with water. The patches prepared in this way were placed on the opposite dorso-lateral areas of the trunk of each animal and were loosely held in contact with the skin by means of a semiocclusive dressing for the duration of the exposure period. Thus, access by the animal to the patch and resultant ingestion/inhalation could be prevented. After 4 hours, the patches were removed, and the exposed skin areas were carefully washed with water without altering the existing response, or the integrity of the epidermis.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 2 out of 6
Remarks:
W32, W42
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal: 1 out of 6
Remarks:
W37
Time point:
24/48/72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal: 1 out of 6
Remarks:
Y27
Time point:
24/48/72 h
Score:
1.66
Max. score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal: 2 out of 6
Remarks:
Y32 and Y18
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal: 2 out of 6
Remarks:
W32 and Y27
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
edema score
Basis:
animal: 1 out of 6
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal: 1 out of 6
Remarks:
W42
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal: 1 out of 6
Remarks:
Y32
Time point:
24/48/72 h
Score:
0.66
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
animal: 1 out of 6
Remarks:
Y32
Time point:
24/48/72 h
Score:
0.66
Max. score:
1
Reversibility:
fully reversible within: 14 days
Irritant / corrosive response data:
Mean irritation indices:
- Erythema and eschar formation: 1.3
- Oedema formation: 1.1
Other effects:
The reactions extended beyond the exposed area in all animals.

Applicant's summary and conclusion

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

Determination of the irritant and corrosive effects on skin of the test substance 3,4-Dichlorbenzotrichlorid was conducted in accordance with the OECD 404. After an acclimation period of at least 14 days, the animals were examined one day prior to the start of the study to establish that they were biologically normal. 6 New Zealand White adult albino rabbits were used in the study.

Approximately 24 hours before the test, fur was removed by clipping from the dorso-lateral area of the trunk (6 x6 cm) of each six rabbits. 500 µL of the test substance was applied to a hypoallergenic Hansamed patch. A further patch was moistened with water. The patches prepared in this way were placed on the opposite dorso-lateral areas of the trunk of each animal and were loosely held in contact with the skin by means of a semiocclusive dressing for the duration of the exposure period. Thus, access by the animal to the patch and resultant ingestion/inhalation could be prevented. After 4 hours, the patches were removed, and the exposed skin areas were carefully washed with water without altering the existing response, or the integrity of the epidermis. The contralateral skin area not treated served as control.

At the end of the study, dermal irritation was scored and recorded at 24, 48 and 72 h, 7 d and 14 d. According to the criteria set up in the CLP Regulation n. 1272/2008, no classification for skin irritation is applied. However, serious lesions and toxic effects other than dermal irritation were also recorded.