Hydrocarbons, C16-C20, n-alkanes, isoalkanes, cyclics, aromatics (2-30 %)

Acute Toxicity: oral

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Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1985/07/11-1985/07/31

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: According to OECD 423 guideline. GLP

Cross-reference

Reason / purpose for cross-reference:

read-across: supporting information

Reference

Endpoint:

acute toxicity: oral

Type of information:

read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

1985/07/11-1985/07/31

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: According to OECD 423 guideline. GLP

Reason / purpose for cross-reference:

read-across source

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

yes

Remarks:

only one dose tested

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Sex: Males (10); Females (10)
- Weight at study initiation: Males (130-135 g), Females (110-115 g)
- Housing: individual
- Acclimation period: 6d

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

A single dose of BP83HF (5 ml/kg; converted to 4.15 g/kg) was administered by oral gavage. An additional group of 5 males and 5 females were sham - dosed and acted as controls.

Doses:

5 ml/kg (converted to 4.15 g/kg)

No. of animals per sex per dose:

Male (10), Female (10); total animals (20)

Control animals:

yes

Details on study design:

The acute oral toxicity of BP83HF was investigated in a group of 5 male and 5 female CD rats of the Sprague - Dawley strain. Each animal received a single oral dose of 5 ml/kg (converted to 4.15 g/kg) administered by gavage. An additional group of 5 males and 5 females were 'sham - dosed and acted as controls. The condition of all animals was observed over a 14 day period following dosing.

Statistics:

Differences between treated and control group mean values for bodyweight gains were analyzed by Student t-test. When individual variance ratios were significant (P < 0.05), Cochran's approximation was applied (Snedecor and Cochran, 1973) .

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 4 150 mg/kg bw

Remarks on result:

other: (converted from 5 mL/kg bw) no mortality noted

Mortality:

No mortality was observed in any of the animals treated with 5 ml/kg (converted to 4.15 g/kg) of BP83HF.

Clinical signs:

other: Transient staining of the urogenital region with test material was observed in all test rats within 24 hours of dosing. Slight flaking of the skin on the feet of these, first noted on Day 7, resolved in most animals prior to termination. During days 0-2,

Gross pathology:

Macroscopic post mortem examination of all animals killed at termination (Day 14) revealed no findings considered to be related to treatment. Although a haemorrhagic focus was seen in the fore-stomach of a female dosed with the test material, this lesion was minimal and was considered to be incidental to treatment with the test material.

Interpretation of results:

other: Not classified

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The LD50 for BP83HF following oral gavage was >5 ml/kg (converted to 4.15 g/kg). Classification as an oral toxicant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.

Executive summary:

The acute toxicity of BP83HF was evaluated in rats via oral gavage at a dose of 5 ml/kg bw(converted to 4.15 g/kg). Observations were made as to the nature, onset, severity, and duration of toxicological signs once per day for a total of 14 days. All animals survived the entire observational period and displayed a low incidence of clinical symptoms.  The animals displayed little or no abnormalities. The LD50 for BP83HF following oral gavage was >5 ml/kg (converted to 4.15 g/kg). Classification as an oral toxicant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

yes

Remarks:

only one dose tested

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Sex: Males (10); Females (10)
- Weight at study initiation: Males (130-135 g), Females (110-115 g)
- Housing: individual
- Acclimation period: 6d

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

A single dose of BP83HF (5 ml/kg; converted to 4.15 g/kg) was administered by oral gavage. An additional group of 5 males and 5 females were sham - dosed and acted as controls.

Doses:

5 ml/kg (converted to 4.15 g/kg)

No. of animals per sex per dose:

Male (10), Female (10); total animals (20)

Control animals:

yes

Details on study design:

The acute oral toxicity of BP83HF was investigated in a group of 5 male and 5 female CD rats of the Sprague - Dawley strain. Each animal received a single oral dose of 5 ml/kg (converted to 4.15 g/kg) administered by gavage. An additional group of 5 males and 5 females were 'sham - dosed and acted as controls. The condition of all animals was observed over a 14 day period following dosing.

Statistics:

Differences between treated and control group mean values for bodyweight gains were analyzed by Student t-test. When individual variance ratios were significant (P < 0.05), Cochran's approximation was applied (Snedecor and Cochran, 1973) .

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 4 150 mg/kg bw

Remarks on result:

other: (converted from 5 mL/kg bw) no mortality noted

Mortality:

No mortality was observed in any of the animals treated with 5 ml/kg (converted to 4.15 g/kg) of BP83HF.

Clinical signs:

other: Transient staining of the urogenital region with test material was observed in all test rats within 24 hours of dosing. Slight flaking of the skin on the feet of these, first noted on Day 7, resolved in most animals prior to termination. During days 0-2,

Gross pathology:

Macroscopic post mortem examination of all animals killed at termination (Day 14) revealed no findings considered to be related to treatment. Although a haemorrhagic focus was seen in the fore-stomach of a female dosed with the test material, this lesion was minimal and was considered to be incidental to treatment with the test material.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The LD50 for BP83HF following oral gavage was >5 ml/kg (converted to 4.15 g/kg). Classification as an oral toxicant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.

Executive summary:

The acute toxicity of BP83HF was evaluated in rats via oral gavage at a dose of 5 ml/kg bw(converted to 4.15 g/kg). Observations were made as to the nature, onset, severity, and duration of toxicological signs once per day for a total of 14 days. All animals survived the entire observational period and displayed a low incidence of clinical symptoms.  The animals displayed little or no abnormalities. The LD50 for BP83HF following oral gavage was >5 ml/kg (converted to 4.15 g/kg). Classification as an oral toxicant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.