Registration Dossier

Toxicological information

Acute Toxicity: dermal

Currently viewing:

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:
other: Sema. 1988. Manual of tests for assessing chemical agents toxicity, 1 ed. Brasilia: MHU.
GLP compliance:
no
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals 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 levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
> 4 300 mg/kg bw
Sex:
male
Dose descriptor:
LD50
Effect level:
> 3 600 mg/kg bw
Mortality:
No animals died during the study.
Clinical signs:
No adverse clinical signs were seen during the study.
Body weight:
Body weight gain was comparable between treatment and control groups.
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.