ethyl 5,5-diphenyl-2-isoxazoline-3-carboxylate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

23 Feb - 09 Mar 1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

Current version adopted in 2017

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

Guideline in place during study conduct: adopted in 1987

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPP 81-2 (Acute Dermal Toxicity)

Version / remarks:

Adopted in 1988

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: Agricultural chemicals, Laws and Regulations Japan, MAFF (p. 20 - 21)

Version / remarks:

1985

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

443-870-0

EC Name:

-

Cas Number:

163520-33-0

Molecular formula:

C18H17NO3

IUPAC Name:

ethyl 5,5-diphenyl-4,5-dihydro-1,2-oxazole-3-carboxylate

Test animals

Species:

rat

Strain:

Wistar

Remarks:

Hoe: WISKf(SPF71)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: SPF breeding colony, Hoechst AG, Kastengrund, Germany
- Females nulliparous and non-pregnant: not specified
- Age at study initiation: males: approx. 8 weeks, females: approx. 11 weeks
- Body weight at study initiation: males: 225 g (mean), 220 - 230 g (range); females: 227 g (mean), 222 - 229 g (range)
- Housing: single housed in Makrolon cages (Type 3) on soft wood granulate
- Diet: Altromin 1324 rat diet (Altromin GmbH, Lage/Lippe, Germany), ad libitum
- Water: tap water in drinking water quality, ad libitum
- Acclimation period: at least 1 day
- Microbiological status : SPF bred animals

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 50 ± 20
- Air changes: fully air-conditioned rooms
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 23 Feb 1994 To: 09 Mar 1994

Administration / exposure

Type of coverage:

occlusive

Vehicle:

other: sesame oil

Details on dermal exposure:

TEST SITE
- Area of exposure: 30 cm² shaved skin of the dorsal area of the trunk
- Type of wrap if used: The treated skin area was covered with a porous gauze and an aluminium foil (6 x 8 cm), which was held in place with an elastic plaster bandage fixed around the animal's body in order to avoid evaporation of the test substance and ingestion of the test substance by the animals.

REMOVAL OF TEST SUBSTANCE
- Washing: residual test substance was removed with warm water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount applied: 0.5 g
- Constant volume or concentration used: yes, limit test
- For solids, paste formed: yes, 0.5 g test substance were moistened with 0.35 mL sesame oil

VEHICLE
- Amount applied: 0.35 mL

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: animals were observed 15, 30, 60 min and 2, 4, and 6 h after dosing, twice daily from Day 2 to 6 and daily thereafter until the end of the observation period; individual body weights were determined weekly
- Necropsy of survivors performed: yes
- Examinations performed: clinical signs, body weight, assessment of macroscopic changes at necropsy

Statistics:

Mean body weights and standard deviations were calculated.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

no indication of skin irritation up to the relevant limit dose level

Mortality:

No mortality occurred during the study period.

Clinical signs:

other: No clinical signs of toxicity were observed during the 15-day observation period in 5/5 male and 4/5 female animals. 1/5 females showed alopecia and an encrusted skin surface on its rump, which did not affect the treated skin area. These findings were con

Gross pathology:

Necropsy revealed no substance-related findings.

Other findings:

No local effects on the treated skin area were observed.

Applicant's summary and conclusion

Interpretation of results:

other: CLP: not classified

Conclusions:

Based on the results of the present study, no classification for acute dermal toxicity according to Regulation (EC) 1272/2008 is warranted.