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Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
(1,3,4,5,6,7-hexahydro-1,3-dioxo-2H-isoindol-2-yl)methyl (1R-trans)-2,2-dimethyl-3-(2-methylprop-1-enyl)cyclopropanecarboxylate
EC Number:
214-619-0
EC Name:
(1,3,4,5,6,7-hexahydro-1,3-dioxo-2H-isoindol-2-yl)methyl (1R-trans)-2,2-dimethyl-3-(2-methylprop-1-enyl)cyclopropanecarboxylate
Cas Number:
1166-46-7
Molecular formula:
C19H25NO4
IUPAC Name:
(1,3-dioxo-1,3,4,5,6,7-hexahydro-2H-isoindol-2-yl)methyl (1R,3R)-2,2-dimethyl-3-(2-methylprop-1-en-1-yl)cyclopropanecarboxylate
Constituent 2
Chemical structure
Reference substance name:
(1,3,4,5,6,7-hexahydro-1,3-dioxo-2H-isoindol-2-yl)methyl (1R-cis)-2,2-dimethyl-3-(2-methylprop-1-enyl)cyclopropanecarboxylate
EC Number:
257-144-4
EC Name:
(1,3,4,5,6,7-hexahydro-1,3-dioxo-2H-isoindol-2-yl)methyl (1R-cis)-2,2-dimethyl-3-(2-methylprop-1-enyl)cyclopropanecarboxylate
Cas Number:
51348-90-4
Molecular formula:
C19H25NO4
IUPAC Name:
(1,3-dioxo-1,3,4,5,6,7-hexahydro-2H-isoindol-2-yl)methyl (1R,3S)-2,2-dimethyl-3-(2-methylprop-1-en-1-yl)cyclopropanecarboxylate
Constituent 3
Chemical structure
Reference substance name:
1,3-dioxo-1,3,4,5,6,7-hexahydro-2H-isoindol-2-yl)methyl (1S,3S)-2,2-dimethyl-3-(2-methylprop-1-en-1-yl)cyclopropanecarboxylate
Cas Number:
1166-48-9
Molecular formula:
C19H25NO4
IUPAC Name:
1,3-dioxo-1,3,4,5,6,7-hexahydro-2H-isoindol-2-yl)methyl (1S,3S)-2,2-dimethyl-3-(2-methylprop-1-en-1-yl)cyclopropanecarboxylate
Constituent 4
Chemical structure
Reference substance name:
(1,3-dioxo-1,3,4,5,6,7-hexahydro-2H-isoindol-2-yl)methyl (1S,3R)-2,2-dimethyl-3-(2-methylprop-1-en-1-yl)cyclopropanecarboxylate
Cas Number:
51348-91-5
Molecular formula:
C19H25NO4
IUPAC Name:
(1,3-dioxo-1,3,4,5,6,7-hexahydro-2H-isoindol-2-yl)methyl (1S,3R)-2,2-dimethyl-3-(2-methylprop-1-en-1-yl)cyclopropanecarboxylate
Test material form:
solid: crystalline
Details on test material:
the racemate is characterized by CAS-number 7696-12-0

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
Animals were housed under standard laboratory conditions, air conditioned with adequate fresh air supply. Environment: with temperature 19 - 24 °C, relative humidity 30 - 70%, with 12 hours light and 12 hours dark cycle, Temperature during the test was recorded once daily.
Housing: Individually housed in standard polypropylene cages (size: L 290 x W 220 x H 140 mm), with stainless steel top grill having facilities for pelletted food and drinking water in glass bottle; bedding: steam sterilized clean paddy husk was used for polypropylene cage housing and changed twice a week.
Diet and water ad libitum.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
corn oil
Details on dermal exposure:
The test item was applied on the prepared area of skin as a paste by adding sufficient volume of corn oil (0.3 ml for male rats and 0.26 ml for female rats). Based on the individual body weight the pre-weighed test item on aluminium foil at 2000 mg/kg body weight was made into paste by adding corn oil as mentioned above and transferred completely to the prepared area of skin of rat.
Duration of exposure:
24 h
Doses:
0.3 ml for male rats and 0.26 ml for female rats
No. of animals per sex per dose:
5 male rats + 5 female rats for each group (test group and control vehicle group)
Control animals:
yes, concurrent vehicle
Details on study design:
Approximately 24 hours before treatment the hair on the dorsolateral thoracic surface of the skin was clipped (approximately 8 x 12 cm) with an electric clipper exposing an area of about 10% of the total body surface.
On test day one, 2000 mg/kg body weight of the test item was made into paste as mentioned above, was spread evenly on the prepared area of skin of all animals and covered with a cotton gauze (4 ply) of size (males: 8 x 5 cm, females: 7 x 5 cm) and secured with adhesive tape wrapped around the torso. After the 24 hour contact period, the dressing was removed. After washing with water, the animals were washed again with Teepol® and one more time with water. Washed animals were wiped dry with a cotton hand towel.
The vehicle control group animals were treated with the vehicle corn oil similarly and the volume of application as a patch was determined based on the approximate volume required to form a paste in treatment group animals and the volume required was 0.3 ml for male rats and 0.26 ml for female rats.

Results and discussion

Preliminary study:
PRE-WEIGHED TEST
Based on the individual body weight, the pre-weighed test item on aluminium foil at 2000 mg/kg body weight was made into paste by adding sufficient volume of corn oil and transferred completely to the prepared area of skin of 4 (2M+2F) rats and covered with cotton gauze and secured in position by adhesive tape wound around torso. There were no toxic signs, local skin reaction and pre-terminal deaths. There were no abnormalities present at necropsy. Hence, the limit dose of 2000 mg/kg body weight was selected for the final study.
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no pre-terminal deaths
Clinical signs:
TOXIC SIGNS: No toxic signs were observed.
LOCAL SKIN REACTION: There were no local skin reactions
Body weight:
All the rats gained weight through the observation period
Gross pathology:
No abnormality was detected.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute dermal minimum lethal dose of tetramethrin tech. grade in Wistar rats is more than 2000 mg/kg body weight.
Executive summary:

Acute dermal toxicity of tetramethrin tech. grade was tested in female and male Wistar rats.

The test item at the doses of '0' (vehicle control - corn oil at volume of 0.3 ml for male rats and 0.26 ml for female rats) and 2000 mg/kg body weight as a paste using corn oil was applied over the prepared area of skin and covered with a cotton gauze (4 ply) of size (size: 8 x 5 cm for males and 7 x 5 cm for females) and secured with an adhesive tape wrapped around torso. After a 24 hour contact period with the skin, the unabsorbed test item was removed by washing and the rats were observed for 15 days. There were no toxic signs, local skin reactions and pre-terminal deaths. The acute dermal minimum lethal dose of tetramethrin tech. grade in Wistar rats is more than 2000 mg/kg body weight.