Pentyl 2-cyano-(3-(6-methoxybenzothiazol-2-ylimino)-2,3-dihydro-1H-isoindol-1-ylidene)acetate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From Aug. 23, 2000 to Nov. 27, 2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material (as cited in study report): FC 84508

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: HARLAN WINKELMANN, Gartenstr. 27, 33178 Borchen, SPF breeding colony
- Age at study initiation: 6-10 wk
- Weight at study initiation: 288± 11 g (males); 212± 12 g (females)
- Fasting period before study: Yes, 16 h
- Housing: MacroIon cages (type 4) on soft wood granulate, one animal/cage
- Diet (e.g. ad libitum): ssnif R/M-H (V 1534), ad libitum
- Water (e.g. ad libitum): Tap water in plastic bottles, ad libitum
- Acclimation period: At least 7 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3 °C
- Humidity (%): 50±20 °C
- Photoperiod (hrs dark / hrs light): 12 h dark/12 h light

IN-LIFE DATES: From: Aug. 23, 2000 To: Sep. 06, 2000

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

other: Tylose H 4000 G4 PHA (0.5 % in deionized water)

Details on dermal exposure:

TEST SITE
- Area of exposure: Dorsal skin of the area (30 cm2)
- Type of wrap if used: Elastic plaster bandage fixed around the animal's body (Fixomull and Elastoplast, 8 cm in width)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, with warm water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): 0.5 g of test substance was moistened with 0.5 mL Tylose H 4000 G4 PHA (0.5 % in deionized water).
- Constant volume or concentration used: yes
- For solids, paste formed: yes

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL Tylose H 4000 G4 PHA (0.5 % in deionized water).

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5/sex/dose

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 d
- Frequency of observations and weighing: Symptoms were recorded twice every day (in the morning and in the afternoon), on weekends
and public holidays only once. The animals were weighed weekly
- Necropsy of survivors performed: yes; animals were killed by carbon dioxide asphyxiation, dissected and examined for macroscopically visible changes.
- Other examinations performed: Clinical signs and body weight

Statistics:

No data

Results and discussion

Preliminary study:

Not applicable

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 mortalities occurred during the whole study.

Clinical signs:

other: No symptoms were observed after administration of 2000 mg/kg body weight. The skin of the animals showed no signs of irritation.

Gross pathology:

No gross pathological changes were observed

Other findings:

No data

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions, the acute dermal LD50 of the test substance was found to be >2000 mg/kg in Sprague-Dawley CD rats

Executive summary:

A study was conducted to assess the acute dermal toxicity of test substance in Sprague-Dawley CD rats according EU Method B.3. and OECD guideline 402 in compliance with GLP.

Following a range-finding study, a group of 10 rats (five males and five females) were applied 0.5 g of test substance moistened with 0.5 mL Tylose H 4000 G4 PHA (0.5 % deionised water), at a dose level of 2000 mg/kg. Following the 24 h exposure period, animals were observed for mortality, skin response and general behavior for 14 d and were then killed and subjected to gross pathological examination.

 

No mortality was observed in the study. All animals appeared normal throughout the 24 h exposure period and the 14 d post-exposure observation period. The skin of the animals showed no signs of irritation.

Three female animals showed disturbance of body weight gain during the first week of the study. Up to the end of the study (Day 15) the body weight gain returned to normal. One male animal suffered a loss of weight between Day 8 and Day 15, the body weight of all animals increased during the observation period.

 

Under the test conditions, the acute dermal LD50 of the test substance was found to be >2000 mg/kg in Sprague-Dawley CD rats