[No public or meaningful name is available]

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

2014-01-08 to 2014-01-22

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

1987

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:

482-220-0

EC Name:

-

Cas Number:

848301-69-9

IUPAC Name:

C18-C50 branched, cyclic and linear hydrocarbons – Distillates

Test animals

Species:

rat

Strain:

other: Wistar: (RccHan; WIST)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories Ltd, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 200 g
- Fasting period before study:
- Housing: housed individually during the exposure period; in groups of 5 by sex for the rest of the study period; housed in polypropylene cages
- Diet: 2014C Teklad Global Rodents diet, ad libitum
- Water: drinking water ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25 °C
- Humidity (%): 30-70 %
- Air changes (per hr): 15 per hour
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: back and flanks
- % coverage: 10 % of the total body surface area
- Type of wrap if used: surgical gauze

REMOVAL OF TEST SUBSTANCE
- Washing (if done): After the 24-hout exposure period the area was wiped with cotton wool moistened with arachis oil BP
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg
- Constant volume or concentration used: yes; 2.48 mL/kg

Duration of exposure:

24 hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were examined at 30 min, 1, 2, and 4 hours post-application, and every day for the 14 day study period. Body weights were recorded prior to the treatment and at days 7 and 14.
- Necropsy of survivors performed: yes; at the end of the study the animals were killed by cervical dislocation; external examination and opening of the abdominal and thoracic cavities were performed at necropsy
- Other examinations performed: behavioural and clinical observations, gross lesions, body weight changes, mortality and any other toxicological effects were noted during the 14 day study period. The test sites were examined for evidence of primary irritation and scored.

Statistics:

No statistics were used in the study.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortalities occured.

Clinical signs:

other: No signs of systemic toxicity were observed.

Gross pathology:

No abnormalities were noted at necropsy.

Other findings:

Slight desquamation was observed in 3 females on days 4, 5 and 6 of the 14-day study period.

Applicant's summary and conclusion

Interpretation of results:

other: EU-GHS criteria not met

Conclusions:

LD50 > 2000 mg/kg bw

Executive summary:

An acute dermal toxicity study for 'Distillates (Fischer-Tropsch), heavy, C18-50-branched, cyclic and linear' was performed to assess the acute dermal toxicity in rat.

A single dose of 2000 mg/kg bw of undiluted test material was applied onto the skin of 5 male and 5 female rats. The test item was held in contact with the skin under semi-occluded dressing for 24 hours. Observations for clinical signs of toxicity were performed at 30 min, 1, 2, and 4 hours post-application and every day for the 14 day study period. Body weights were recorded prior to the treatment and at days 7 and 14. At the end of the study the tested animals were killed by cervical dislocation. External examination and opening of the abdominal and thoracic cavities were performed at necropsy. Behavioural and clinical observations, gross lesions, body weight changes, mortality and any other toxicological effects were noted during the 14 day study period. The test sites were examined for evidence of primary irritation and scored.

No mortalities occured at during the 14 -day study period. There were no signs of systemic toxicity. All females showed no body loss or gain in body weight during the first week and expected gain in body weight in the second week. The males showed expected gain in body weight during the 14 day study period. No abnormalities were noted at necropsy.

The LD₅₀ value for 'Distillates (Fischer-Tropsch), heavy, C18-50-branched, cyclic and linear' was concluded to be > 2000 mg/kg bw. The study was conducted according to OECD TG 402, and in compliance with GLP.