Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
27 Jan - 10 Feb 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-Guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
GLP compliance:
yes
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2-Ethylhexyl benzoate
- Physical state: clear colourless liquid
- Analytical purity: 99.734%
- Impurities (identity and concentrations): 2-Ethyl-4-methyl-1-pentyl benzoate 0.209%, C8 benzoate 0.023%, 2-Ethylhexyl phthalate 0.004%, unknown impurities 0.03%
- Lot/batch No.: 9915-140-2
- Expiration date of the lot/batch: 2000-12-04
- Storage condition of test material: room temperature in light, in brown glass bottle

Test animals

Species:
rat
Strain:
other: Hsd:Sprague-Dawley (CD)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan UK Ltd., Bicester, Oxon, UK
- Age at study initiation: 8-11 weeks
- Weight at study initiation: 222-265 g
- Housing: animals were housed individually in metal cages (RS Biotech Sub-Dividable Rodent Cages) until Day 5 when they were returned to group housing.
- Diet: standard laboratory rodent diet (Special Diet Services RM1(E) SQC expanded pellet), ad libitum
- Water: drinking water, ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 5 x 5 cm clipped skin of the dorso-lumbar region
- % coverage: 10%
- Type of wrap if used: The test material was held in contact with the skin with porous gauze held in place with a non-irritating dressing, and further covered by a waterproof dressing encircled firmly around the trunk of the animal.

REMOVAL OF TEST SUBSTANCE
- Washing: the dressings were carefully removed and the treated area of skin was washed with warm water (30-40 °C). The treated area was blotted dry with absorbent paper.
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5.24 mL/kg bw (5004 mg/kg bw with a specific gravity of 0.955 g/mL)


Duration of exposure:
24 h
Doses:
5004 mg/kg bw
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: animals were checked at least twice daily for mortalities. Animals were observed for clinical signs soon after dosing and at frequent intervals for the remainder of Day 1 and thereafter, once in the morning and at the end of the experimental day. Body weight was recorded on Day 1, 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
>= 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study period.
Clinical signs:
No systemic clinical signs of toxicity were observed up to the end of the 14-day observation period. Transient very slight dermal irritation (Grade 1 erythema with or without Grade 1 edema) was seen in all animals following removal of the dressing, resolving completely by Day 4.
Body weight:
A loss in body weight was recorded for one female and low body weight gains were noted for the four remaining females on Day 8. All other animals were considered to have achieved satisfactory body weight throughout the study.
Gross pathology:
Necropsy revealed no substance-related findings.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
CLP: not classified