Benzene, C10-13-alkyl derivs.

Endpoint summary

Description of key information

The oral LD50 is >5000 mg/kg bw (highest tested concentration) in rats (OECD 401, under GLP)

The dermal LD50 is > 2000 mg/kg bw (highest tested concentration) in rats (OECD 402, under GLP)

Acute toxicity studies in rats via the oral and dermal exposure routes resulted in no mortality or other signs of toxicity at the limit doses, therefore no classification for acute toxicity is warranted.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

Before 2002

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Morini - S. Polo d'Enza
- Weight at study initiation: 140 - 200 g
- Housing: 5 animals of same sex in polycarbonate cages, indentified by coloring with indelible ink on various areas of the body
- Diet: complete pellet diet
- Water: Purified water, ad libitum

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 hrs light/12 hrs dark

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE:
- Concentration in vehicle: 500 mg/mL

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

DOSAGE PREPARATION: test substance was dissolved in warm water

Doses:

5000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations were made daily, body weights were taken before the beginning of the study, on day 7, and at study termination
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

No animals died during the study.

Clinical signs:

other: Piloerection was observed in several of the animals during days 3 and 4 of the study.

Gross pathology:

One male rat showed redness in the stomach. Another male rat showed bloating in the stomach.

Table 1: Results of Acute Oral Toxicity Study – Body Weights (g)

Animal	Initial Body Weight	Final Body Weight
Males
1	150	205
2	155	210
3	150	205
4	170	215
5	175	215
Females
1	170	215
2	165	210
3	170	215
4	175	220
5	145	190

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this study, the LD50 for male and female rats was greater than 5000 mg/kg bw. The test substance is not classified as acute toxic under EU GHS guidelines.

Executive summary:

This study examined the acute toxicity of the test substance to rats. Five male and 5 female rats were given a dose of 5000 mg/kg bw of test substance by oral gavage. The animals were then monitored for the next 14 days for mortality and signs of toxicity. At the end of the study, the animals were sacrificed and gross pathology performed. No animals died during the study. The LD50 for rats by oral exposure was greater than 5000 mg/kg bw. The test substance is not classified as acute toxic under EU GHS guidelines.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

Key study is reliable without restriction.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

Before 9 Oct 2017

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hacking and Churchill Limited
- Age at study initiation: 6 - 8 weeks
- Weight at study initiation: 206 - 250 g
- Housing: individually in metal cages, identified by cage number and ear punching
- Diet: Spratt's Rodent Breeding Diet (LAD 1), ad libitum
- Water: Purified water, ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 55
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hrs

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: dorso-lumbar region
- coverage: 10%
- Type of wrap if used: gauze held in place with impermeable dressing over the trunk

REMOVAL OF TEST SUBSTANCE
- Washing: 30 - 40 °C water
- Time after start of exposure: 24 hrs

TEST MATERIAL
- Amount applied: 2.0 g/kg bw

Duration of exposure:

24 hrs

Doses:

2.0 g/kg bw

No. of animals per sex per dose:

5 male and 5 females

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations - twice daily for mortality and signs of toxicity, daily for skin observations, body weights were taken on days 1, 8, and 15
- Necropsy of survivors performed: yes

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No animals died during the study.

Clinical signs:

other: Nine of the animals developed a slightly raised red area at the dose site on day 6. Scabs formed at this area by day 9. All animals were fully recovered by the end of the experiment.

Gross pathology:

No abnormalities were noted at autopsy.

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 of the test substance was greater than 2000 mg/kg.

Executive summary:

This study determined the acute dermal toxicity of the test substance in rats. Five male and 5 female rats were exposed to 2000 mg/kg bw of test substance dermally. Exposure lasted 24 hrs, after which the test substance was removed by washing. The animals were observed for the next 14 days for clinical signs and mortality. All animals were necropsied at the end of the experiment. No animals died during the study. The dermal LD50 in rats is > 2000 mg/kg bw. The test substance is not classified as a dermal toxicant under EU GHS guidelines.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

Key study is reliable without restriction.

Additional information

Acute toxicity via oral route:

This study examined the acute toxicity of the test substance to rats. Five male and 5 female rats were given a dose of 5000 mg/kg bw of test substance by oral gavage. The animals were then monitored for the next 14 days for mortality and signs of toxicity. At the end of the study, the animals were sacrificed and gross pathology performed. No animals died during the study. The LD50 for rats by oral exposure is > 5000 mg/kg bw. The test substance is not classified as acutely toxic.

Acute toxicity via dermal route:

This study determined the acute dermal toxicity of the test substance in rats. Five male and 5 female rats were exposed to 2000 mg/kg bw of test substance dermally. Exposure lasted 24 hrs, after which the test substance was removed by washing. The animals were observed for the next 14 days for clinical signs and mortality. All animals were necropsied at the end of the experiment. No animals died during the study. The dermal LD50 in rats is > 2000 mg/kg bw. The test substance is not classified as a dermal toxicant.

Justification for classification or non-classification

Based on the result of the acute oral and dermal toxicity study classification for acute toxicity is not warranted in accordance with EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation No. (EC) 1272/2008.