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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
03 October 1979 - 30 October 1979
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
No data on environmental conditions.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2,6-dimethyloct-7-en-2-yl acetate
EC Number:
258-751-7
EC Name:
2,6-dimethyloct-7-en-2-yl acetate
Cas Number:
53767-93-4
Molecular formula:
C12H22O2
IUPAC Name:
2,6-dimethyloct-7-en-2-yl acetate
Test material form:
liquid

Test animals

Species:
rat
Strain:
other: TacN (SD) fBR
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Taconic Farms (Germantown, N.Y.)
- Females (if applicable) nulliparous and non-pregnant: no data
- Age at study initiation: no data
- Weight at study initiation: males: 200 - 237g; females: 182 - 207g
- Fasting period before study: no
- Housing: The animals were housed singly in wire cages.
- Diet: Free access to Purina Rodent Laboratory Chow 5001
- Water: Free access to water
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
No data.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Range finding test: Two rats of each sex were used per dose. Each animal received a single dose of the test substance. Rats were observed for the next 72 hours to determine the mortality. In other respects the test system was similar to that described below. The doses were 50, 160, 500, 1600 or 5000 mg/kg bw.

TEST SITE
Experimental procedure:
On the day prior to treatment, the backs of the rats were clipped from the scapular region to the hips using an Angra clipper blade. Before application, a non-lubricated condom with the closed end cut off was slipped over the tail and hind legs, and it was adjusted to cover the trunk between the shoulder girdle and the hips. The test substance was applied evenly over the back using a B-D disposable syringe and a 14G gavage needle.
- Type of wrap if used: 2 inch elastic adhesive bandage (Elastikon)

REMOVAL OF TEST SUBSTANCE
- Washing: None, the excess material was removed by wiping with a dry cloth.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount applied: 5.75 mL/kg bw
Duration of exposure:
24 hours
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for mortality and pharmacotoxic signs at 1, 3, 5 and 24 hours following dosing and twice daily (once daily on weekends) for the remainder of the 14 day observation period. Surviving animals were weighed at the end of the observation period.
- Necropsy of survivors performed: Yes, all the animals underwent a gross necropsy at the end of the experiment. The animals were killed using ether.

Results and discussion

Preliminary study:
In a preliminary assay two rats of each sex were treated by application of the test substance to the skin at 50, 160, 500, 1600 or 5000 mg/kg bw. There were no deaths during the 72 hour observation period.
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred.
Clinical signs:
The only clinical signs which appeared following dosing were lethargy in all animals and chromodacryorrhea in 1 male and 4 females and chromorhinorrhea in 1 male and 3 females. All animals were normal by the second day and remained healthy througout the study.
Body weight:
All males and four females gained weight (>10g) in a normal manner, but two females gained 10g or less.
Gross pathology:
There were no signs indicative of toxicity in any of the 12 animails necropsied at termination.

Applicant's summary and conclusion

Interpretation of results:
other: Not acute harmful.
Remarks:
According to Regulation (EC) No. 1272/2008 and its amendments.
Conclusions:
An LD50 of >5000 mg/kg bw was determined in the acute dermal toxicity study with rats.
Executive summary:

In an acute dermal toxicity study a group of 12 rats (6 males and 6 females) were dermally exposed to 5000 mg/kg bw of the substance. The rats were observed for signs of toxicity and clinical signs for a period of 14 days. No mortality occured. The only clinical signs which appeared following dosing were lethargy in all animals and chromodacryorrhea in 1 male and 4 females and chromorhinorrhea in 1 male and 3 females. All animals were normal by the second day and remained healthy througout the study.

Based on the results, an LD50 of >5000 mg/kg bw was determined in the acute dermal toxicity study with rats.

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