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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:
weight of evidence
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report Date:
2013

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: White tablets
Details on test material:
- Name of test material (as cited in study report): chlorocresol
- Substance type: Organic
- Physical state: solid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Institute for Industrial Research & Toxicology
- Sex: Female
- Age at study initiation: 10 to 12 weeks
- Weight at study initiation: 2.15 kg
- Housing: Animal was housed individually in stainless steel cages provided with stainless steel mesh bottom and facilities for food and water bottle
- Diet (e.g. ad libitum): Pelleted feed supplied by Pranav agro Industries Ltd., B7/6 Ramesh Nagar, Delhi
- Water (e.g. ad libitum): Pelleted feed supplied by Pranav agro Industries Ltd., B7/6 Ramesh Nagar, Delhi
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-25°C
- Humidity (%): 40-60%
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): illumination cycle set to 12 hours artificial fluorescent light and 12 hours dark

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
0.5 gm
Duration of treatment / exposure:
no data
Observation period:
72 hours
Number of animals:
1
Details on study design:
EXPERIMENTAL PROCEDURE
Preparation of Animals:
The animal was prepared 24 hrs prior to application of test product. The furs from the dorsal area of trunk of animal were removed with electric clippers exposing an area measuring approximately 6 cm2 of body surface area of animal. The care was taken such that abrasion penetrated the Stratum corneum only and not dermis.

Application of test product:
The 0.5 gm of test compound was applied on a small area (approximately 6 cm2) of intact skin site. Each site of application was covered with impervious dressing which was secured in position with adhesive tape. The treated animal was then housed individually and plastic collar was put around their necks in order to prevent access by the animal to the patch and resultant ingestion of the test product. After patch removal, the dressing and unabsorbed test product was removed and the site of application was cleaned with lukewarm water.

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 4 hrs
Max. score:
8
Reversibility:
fully reversible within: 1 week
Remarks on result:
other: severe necrosis at the site of application
Irritant / corrosive response data:
Skin reaction
The test compound Chlorocresol (CAS No.: 59-50-7) when applied at the dose level of 0.5 gm on shaven back skin of rabbit produced severe necrosis at the site of application of test compound after four hours of patch removal. The test compound produced necrosis to epidermal layer and complete layer of necrotic tissue was removed after one week.

Clinical Signs
The test compound Chlorocresol (CAS No.: 59-50-7) applied on the shaven back skin of rabbit did not produce any clinical signs of toxicity during the entire observation period

Any other information on results incl. tables

CLINICAL SIGNS

SEX

ANIMAL NO.

Time (Min.)

Time (Hours)

3

1

4

24

FEMALE

01

N

N

N

N

N: No Clinical Signs

C: Clinical Signs Observed

Applicant's summary and conclusion

Interpretation of results:
Category 1 (corrosive)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test compound Chlorocresol when applied at the dose level of 0.5 gm on shaven back skin of rabbit produced severe necrosis at the site of application of test compound after four hours of patch removal. The test compound produced necrosis to epidermal layer and complete layer of necrotic tissue was removed after one week
Executive summary:

The test compound Chlorocresol when applied at the dose level of 0.5 gm on shaven back skin of rabbit produced severe necrosis at the site of application of test compound after four hours of patch removal. The test compound produced necrosis to epidermal layer and complete layer of necrotic tissue was removed after one week.

Based on the results obtained from present study, it can be concluded that the test compound Chlorocresol produced corrosive effect to skin of the New Zealand white rabbits when applied dermally under test condition