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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Not reported
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report date:
1976

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
cis-2-tert-butylcyclohexyl acetate
EC Number:
243-718-1
EC Name:
cis-2-tert-butylcyclohexyl acetate
Cas Number:
20298-69-5
Molecular formula:
C12H22O2
IUPAC Name:
2-tert-butylcyclohexyl acetate
Test material form:
liquid
Details on test material:
Test material used is consistent with the substance identity as described in section 1.2 of IUCLID - company composition for the quality described under the common name Verdox.

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Doses:
1.31, 3.2, 5.0 and 6.5 g/kg bw
No. of animals per sex per dose:
10 / dose, sex unknown
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observation: at 1-4 hours, afterwards daily
- Necropsy of survivors performed: not clear from report

Results and discussion

Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
4 600 mg/kg bw
Based on:
test mat.
95% CL:
>= 2 700 - <= 7 800
Mortality:
1 animal died on day 7 in the group dosed with 1.31 g/kg bw; 5 animals died on the first day in the group dosed with 3.2 g/kg bw; 4 animals died on day 1 and 2 on day 2 in the group dosed with 5.0 g/kg bw and 3 animals died on day 1 and 1 on day 2 in the group dosed with 6.5 g/kg bw.
Clinical signs:
other: No symptoms were observed in rats dosed with 1.31 g/kg bw. In the group dosed with 3.2 g/kg bw, ataxia was observed in half of the animals, piloerection in 2-3 animals. In the group dosed with 5.0 g/kg bw, lethargy and tetanic convulsion were observed at
Gross pathology:
Very dark lungs were observed in 5 rats of 3.2 g/kg bw group; in 6 rats of 5.0 g/kg bw group and in 4 rats of 6.5 g/kg bw group. Very red stomach was observed in 1 rat from 3.2 g/kg bw group, 3 rats from 5.0 g/kg bw group and 1 rat from 6.5 g/kg bw group. Very red small intesting was found in 4 rats from 3.2 g/kg bw group, 5 rats from 5.0 g/kg bw group, and 1 rat from 6.5 g/kg bw group. Blood around nose and mouth was observed in 5 rats from 3.2 g/kg bw group, 2 rats from 5.0 g/kg bw group, and 4 rats from 6.5 g/kg bw group.

Applicant's summary and conclusion

Interpretation of results:
other: Not acute harmful
Remarks:
in accordance with EU CLP (1272/2008 and its updates)
Conclusions:
A LD50 of 4600 mg/kg bw (95% CI = 2700-7800) was obtained in the acute oral toxicity study with rats.
Executive summary:

In an acute oral toxicity study with rats, similar to OECD TG 401 but without GLP, the LD50 was 4600 mg/kg bw (95% CI - 2700 -7800). Groups of 10 animals (sex, strain and age unspecified) were dosed with 1.3, 3.2, 5.0 and 6.5 g/kg bw and observed for 14 days. The numbers of animals that died were 1 at 1.31 g/kg bw, 5 at 3.2 g/kg bw, 6 at 5.0 g/kg bw, and 4 at 6.5 g/kg bw. Clinical findings included ataxia, piloerection, lethargy, convulsions and ptosis. Necropsy findings included very dark lungs, very red stomach and small intestines, and blood around the nose and mouth.