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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
11 - 25 Nov 1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
No information on purity was given and reduced number of test animals per sex.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
1981
Deviations:
yes
Remarks:
no data on purity of test substance, only 2 animals per sex instead of 5 animals per sex
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-Hepten-4-one, 5-methyl-, (2E)-
EC Number:
600-299-3
Cas Number:
102322-83-8
Molecular formula:
C8H14O
IUPAC Name:
2-Hepten-4-one, 5-methyl-, (2E)-

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: approx. 10-12 weeks
- Weight at study initiation: 228-293 g (males), 197-234 g (females)
- Housing: individually during the 24 h exposure period and subsequently up to 4 animals of the same sex per cage in polypropylene cages, bedding sawdust
- Diet: Rat and Mouse Expanded Diet No.1 (Special Diets Services Limited, Witham, UK), ad libitum
- Water: mains tap water, ad libitum
- Acclimation period: minimum 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21
- Humidity (%): 45-65
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: skin of the dorsal, lateral and ventral regions (6 cm x 12 cm)
- % coverage: 10%
- Type of wrap if used: The treated skin was covered with a surgical gauze patch (7 cm x 4 cm) which was held in place with a strip of elastic adhesive bandage (7.5 cm wide and 25-30 cm long) wrapped around the trunk.

REMOVAL OF TEST SUBSTANCE
- Washing: The skin and surrounding hair were sponged thoroughly with warm water, rinsed and dried using absorbant paper.
- Time after start of exposure: 24 h

TEST MATERIAL
- Amounts applied: 0.06, 0.47, 2.33 and 5.82 mL/kg bw
- Constant concentration used: yes
Duration of exposure:
24 h
Doses:
50, 400, 2000 and 5000 mg/kg bw
No. of animals per sex per dose:
2
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
Frequency of observations and weighing: Animals were observed 1 and 4 h after administration and subsequently once daily for 14 days. Mortality and evidence of overt toxicity was recorded at each observation. Individual body weights were determined on Days 0, 7 and 14.
- Necropsy of survivors performed: yes

Results and discussion

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 during the study period.
Clinical signs:
No clinical signs of toxicity were noted during the 14-day observation period.
Body weight:
All treated animals showed normal bodyweight gains during the study period.
Gross pathology:
No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
In this acute dermal toxicity study a LD50 value > 5000 mg/kg bw in male and female rats was found.
Executive summary:

An acute dermal toxicity study in rats was performed according to OECD 402 with 50, 400, 2000 and 5000 mg/kg bw of the test substance with 2 animals per sex and dose. No mortality was observed and the animals showed no signs of toxicity. Due to these results it was concluded that the dermal LD50 was > 5000 mg/kg bw in rats.