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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
December 1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Old study (pre-OECD and pre-GLP) but comparable to OECD test guideline No. 402 with deviations: only 3 rabbits per sex were used.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
only 3 animals/sex; environmental conditions not reported
Principles of method if other than guideline:
Protocol #DLD (11/7/78) supplied by IFF and dated 12 October 1978
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
trans-4-tert-butylcyclohexyl acetate
EC Number:
217-598-6
EC Name:
trans-4-tert-butylcyclohexyl acetate
Cas Number:
1900-69-2
Molecular formula:
C12H22O2
IUPAC Name:
trans-4-tert-butylcyclohexyl acetate
Constituent 2
Chemical structure
Reference substance name:
cis-4-tert-butylcyclohexyl acetate
EC Number:
233-881-7
EC Name:
cis-4-tert-butylcyclohexyl acetate
Cas Number:
10411-92-4
Molecular formula:
C12H22O2
IUPAC Name:
cis-4-tert-butylcyclohexyl acetate
Test material form:
liquid
Details on test material:
- Description: clear liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: C.S.E. colony located in Brancheville, N.J.
- Age at study initiation: young adult
- Weight at study initiation: 2.45-3.50 kg
- Housing: singly
- Diet (e.g. ad libitum): Purina Rabbit Chow
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
Standard laboratory conditions

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: shaved skin on the back
- % coverage: approximately 20 %
- Type of wrap if used: plastic sleeves ('Baggies')

REMOVAL OF TEST SUBSTANCE
- Washing (if done): disposable napkin moistened with saline
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5 mL/kg bw

Rabbits were placed in restrainers for the 24 hour period following application.
Duration of exposure:
24 hours
Doses:
5 mL/kg bw
No. of animals per sex per dose:
3
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations (signs of toxicity and death): twice daily (once daily on Saturday and Sunday)
- Frequency of observations and weighing: on the day of dosing and before necropsy
- Necropsy of survivors performed: yes
Statistics:
none

Results and discussion

Preliminary study:
not applicable
Effect levelsopen allclose all
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 mL/kg bw
Based on:
test mat.
Key result
Sex:
male/female
Dose descriptor:
LD0
Effect level:
>= 5 mL/kg bw
Based on:
test mat.
Mortality:
No animal died during the study
Clinical signs:
Slight to moderate erythema was observed during the first 24 hours after application. All rabbits exhibited a slight scaliness over the treated area, which was first observed on Day 8 and persisted to the end of the study.
Body weight:
no effect
Gross pathology:
Agonal subcapsular haemorrhage observed in the right or left kidney in 2 rabbits. Pale liver in 1 rabbit.
Other findings:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Dermal LD50Combined > 5 mL/kg bw (> 4680 mg/kg bw)
Under the test conditions, the test material is not classified according to the Regulation EC No. 1272/2008 (CLP) and to the GHS.
Executive summary:

In a limit acute dermal toxicity study performed before but similarly to the OECD guideline No. 402, groups of young adult albino New Zealand rabbits (3/sex) were occlusively exposed to undiluted test material for 24 hours at dose of 5 mL/kg bw (ca. 4680mg/kg bw; density = 0.936). The animals were observed for mortality, clinical signs including dermal reactions and body weight for 14 days and then necropsied for macroscopic observations.

 

No mortality occurred during the study and no clinical signs were observed. There was no adverse effect on bodyweight gain. Slight to moderate erythema was observed during the first 24 hours after application. All rabbits exhibited a slight scaliness over the treated area, which was first observed on Day 8 and persisted to the end of the study.

 

Dermal LD50Combined > 5 mL/kg bw (> 4680 mg/kg bw)

 

Under the test conditions, the test material is not classified according to the Regulation EC No. 1272/2008 (CLP) and to the GHS.

This study is considered as acceptable and satisfies the requirement for acute dermal toxicity endpoint.