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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:
other: in accordance with guidelines

Data source

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

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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 #1
Time point:
other: 14 d
Score:
1
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 14 d
Score:
0.3
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 14 d
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 14 d
Score:
3
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 14 d
Score:
1
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 14 d
Score:
1
Irritation parameter:
edema score
Basis:
animal #4
Time point:
other: 14 d
Score:
1.7
Irritation parameter:
edema score
Basis:
animal #4
Time point:
other: 14 d
Score:
0.3
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
other: 14 d
Score:
2
Irritation parameter:
edema score
Basis:
animal #5
Time point:
other: 14 d
Score:
0.7
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
other: 14 d
Score:
2
Irritation parameter:
edema score
Basis:
animal #6
Time point:
other: 14 d
Score:
1
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.

Any other information on results incl. tables

INTERPRETATION CRITERIA

  INTERPRETATION IRRITATION INDEX 
No irritation  0.00 to 0.99 
Slight irritation  1.00 to 1.99 
Moderate irritation  2.0 to 2.99 
Severe irritation  3.0 to 4.0  
Corrosive  irreversible extensive tissue damage

Applicant's summary and conclusion

Interpretation of results:
Category 3 (mild irritant) based on GHS criteria
Conclusions:
Interpretation of the registered data was based on the nature, intensity, and reversibility of the observed responses. The test substance 3,4-Dichlorbenzotrichlorid resulted to be moderately irritant to the skin, in an exposure period for rabbits of4 hrs.
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. The degree of erythema/eschar formation and oedema formation was recorded as pecified by Draize and any serious lesions and toxic effects other than dermal irritation were also recorded.