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Administrative data

Description of key information

No mortality was observed in acute oral and dermal studies performed on a read-across source substance of Benzene, C15-16-alkyl derivs.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Test procedure according to national standards.
Qualifier:
according to guideline
Guideline:
other: EEC Directive 67/548
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 (e.g. ad libitum): complete pellet diet
- Water (e.g. ad libitum): 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 (if unusual): test substance was dissolved in warm water

Doses:
5000 mg/kg
No. of animals per sex per dose:
5 animals of each sex per dose
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, other:
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
No animals died during the study.
Clinical signs:
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.

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:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 for male and female rats is >5000 mg/kg bw. The test substance is not classified as toxic under EU GHS guidelines.
Executive summary:

In cases where no data were available on the target substance, Benzene, C15 -16 -alkyl derivs., data were read across from a structurally related material (the test substance).

This study examined the acute toxicity of the test substance to rats. 5 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 toxic under EU GHS guidelines.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

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:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study by OECD methods.
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
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 (e.g. ad libitum): Spratt's Rodent Breeding Diet (LAD 1), ad libitum
- Water (e.g. ad libitum): 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 light/12 hrs dark

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 (if done): 30-40 degree C water
- Time after start of exposure: 24 hrs


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 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, bodyweights were taken on days 1, 8, and 15
- Necropsy of survivors performed: yes
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No animals died during the study.
Clinical signs:
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.
Body weight:
Body weights were normal.
Gross pathology:
No abnormalities were noted at autopsy.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 of LAB was greater than 2000 mg/kg.
Executive summary:

In cases where no data were available on the target substance, Benzene, C15 -16 -alkyl derivs., data were read across from a structurally related material (the test substance).

This study determined the acute dermal toxicity of the test substance in rats. 5 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

Additional information

In cases where no data were available on the target substance, Benzene, C15-16-alkyl derivs., data were read across from a structurally related material (the test substance).

No mortality was observed in acute oral and dermal studies performed on a read-across substance of Benzene, C15 -16 -alkyl derivs.

The oral key study ( ANON 1992a, Biolab SGS Report No. 92/8521) examined the acute toxicity of the test substance to rats. Five male and five 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. Some piloerection was observed in several of the animals during days 3 and 4 of the study. One male rat showed redness in the stomach. Another male rat showed bloating in the stomach. The LD50 for rats by oral exposure is >5000 mg/kg bw. The test substance is not classified as toxic.

The dermal key study (Kynoch 1984) determined the acute dermal toxicity of the test substance in rats. Five male and five 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. 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. All body weights were normal. No abnormalities were noted at autopsy. Therefore, 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