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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:
2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
the racemate is characterized by CAS-number 7696-12-0
Specific details on test material used for the study:
Batch no.: TT-SF-01-001

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Toxicology Department Rallis Research Centre Bangalore - 560 058, INDIA
- Age at study initiation: 4 - 5 months
- Weight at study initiation: 2.33 - 2.56 kg
- Housing:Housed individually in fibre board cages (size: L 77 x B 54 x H 63 cm) having provision for pelletted diet and drinking water. Bedding: Steam sterilized paddy husk changed twice a week.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: Seven days under laboratory conditions afte veterinary examination.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 23 °C
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 h/12 h

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
other: corn oil
Controls:
yes, concurrent vehicle
Amount / concentration applied:
0.5 g of the finely ground test item
Duration of treatment / exposure:
4 hours
Observation period:
72 h
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: 6 cm² (2 x 3 cm)
- Type of wrap if used: The control and test patches were secured in position by an adhesive tape `Johnson-plast USP; (manufactured by Johnson & Johnson Ltd., Mumbai, INDIA a trade mark of Johnson & Johnson, USA) and a crepe elastic bandage was wrapped around the torso.

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

OBSERVATION TIME POINTS
1, 24, 48, 72 h

SCORING SYSTEM:
- Method of calculation: numerical scoring system of Draize, et.al.,

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
There were no skin reactions.
Other effects:
PRE-TERMINAL DEATHS: There were no pre-terminal deaths
BODY WEIGHTS: The body weights of all the rabbits increased through the observation period.
TOXIC SIGNS: There were no toxic signs.
NECROPSY: No abnormality was detected

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
It is concluded that the test item tetramethrin tech. grade is classified as non-irritant to the intact skin of New Zealand white rabbits
Executive summary:

The test item tetramethrin tech. grade was tested for its skin irritation potential on the intact skin of New Zealand white rabbits. A quantity of 0.5 g of the finely ground test item was moistened with corn oil on aluminium foil to form a paste and transferred on to the cotton gauze of size approximately 6 cm² (2 x 3 cm) and applied over the prepared area of the skin. Cotton gauze of similar size without the test item but with the vehicle (corn oil) was applied on the prepared skin 3 - 4 cm anterior to the test patch to serve as control patch. Both patches were secured to the body of the animal by adhesive tape and a crepe elastic bandage. The rabbits were then restrained using Elizabethan collar. The contact period was 4 hours.

The skin reactions were scored as per Draize's evaluation method at 1, 24, 48 and 72 hours post removal of the test patch. No erythema and no edema were observed at 24, 48 and 72 hours post exposure and consequently, the test item tetramethrin tech. grade is not classified as corrosive or irritant to the intact skin of New Zealand white rabbits.