Benzene, mono-C10-13-alkyl derivs., distn. residues

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

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

Adequacy of study:

key study

Study period:

1991

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Sema. 1988. Manual of tests for assessing chemical agents toxicity, 1 ed. Brasilia: MHU.

GLP compliance:

no

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Benzene, mono-C12-14-alkyl derivs., fractionation bottoms

EC Number:

271-073-6

EC Name:

Benzene, mono-C12-14-alkyl derivs., fractionation bottoms

Cas Number:

68515-32-2

IUPAC Name:

271-073-6

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 241-267 g males, 180-208 g females
- Housing: conventional breeding station
- Diet (e.g. ad libitum): available
- Water (e.g. ad libitum): available


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

Administration / exposure

Type of coverage:

not specified

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 35-53 cm2 males; 33-42 cm2 females
- % coverage: less than 10% of body surface
- Type of wrap if used: Elizabethan collars were placed on animals to prevent ingestion of test substance.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hrs


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1 ml
- Constant volume or concentration used: yes

Duration of exposure:

24 hrs

Doses:

0, 3600 (males), or 4300 mg/kg (females)

No. of animals per sex per dose:

Five of each sex per dose were tested.

Control animals:

yes

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 every 7 days
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

> 4 300 mg/kg bw

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

> 3 600 mg/kg bw

Mortality:

No animals died during the study.

Clinical signs:

other: No adverse clinical signs were seen during the study.

Gross pathology:

No abnormal pathological finding were noted.

Other findings:

Doses up to 4300 mg/kg did not cause death or produce clinical, behavioral, or anatomical alterations in female rats. Doses up to 3600 mg/kg bw did not produce adverse effects in male rats.

Any other information on results incl. tables

Average Body Weight Gain (g)

	Control	3600 mg/kg bw (males) 4300 mg/kg bw (females)
Males	17.2	33.0
Females	12.4	13.4

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The dermal LD50 in female rats was > 4300 mg/kg bw, and in male rats was > 3600 mg/kg bw.

Executive summary:

This study examined the acute dermal toxicity of heavy alkylates. Groups of 5 male and 5 female rats were exposed to concentrations of 0, 3600 (males), and 4300 mg/kg bw (females) dermally. Animals were observed for the next 14 days for mortality and clinical signs. Animals were weighed every 7 days. At the end of the study, animals were necropsied. No animals died during the study, and no adverse clinical signed were noted. Body weight gains of treated animals were also comparable to controls. The acute dermal LD50 for both female rats was > 4300 mg/kg bw, and male rats was > 3600 mg/kg bw.