Reaction mass of 3,5,6,6-tetramethyl-4-methyleneheptan-2-one and (E)-3,4,5,6,6-pentamethylhept-3-en-2-one

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

3 Sep 1980 to 17 Sep 1980

Reliability:

2 (reliable with restrictions)

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)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of (E)-3,4,5,6,6-pentamethylhept-3-en-2-one and 3,5,6,6-tetramethyl-4-methyleneheptan-2-one

EC Number:

946-245-5

Molecular formula:

C12H22O

IUPAC Name:

Reaction mass of (E)-3,4,5,6,6-pentamethylhept-3-en-2-one and 3,5,6,6-tetramethyl-4-methyleneheptan-2-one

Test material form:

liquid

Details on test material:

According to ECHA communication with reference to Annotation number: SUB-C-2114629169-42-01/F, the substance ID for Koavone has been changed with EC# from 939-627-8 to 946-245-5, and the IUPAC name from Reaction mass of (3R,5R)-3,5,6,6-tetramethyl-4-methylideneheptan-2-one and (3R,5S)-3,5,6,6-tetramethyl-4-methylideneheptan-2-one and (E)-3,4,5,6,6-pentamethylhept-3-en-2-one to Reaction mass of (E)-3,4,5,6,6-pentamethylhept-3-en-2-one and 3,5,6,6-tetramethyl-4-methyleneheptan-2-one.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hilltop Lab Animals, Inc.
- Age at study initiation: Approximately 6 weeks
- Weight at study initiation: male rats was 197 to 234 grams and for the female rats was 141 to 181 grams
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days
- Housing: The rats were individually housed in stainless steel cages suspended above the droppings..

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not reported
- Humidity (%): Not reported
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: 3 Sep 1980 to 17 Sep 1980

Administration / exposure

Type of coverage:

open

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: The dorsal skin area centered about the interscapular region. The fur was removed with an electric clipper the previous day.

TEST MATERIAL
- Amount applied: 0.5 mL/100 gram of body weight (applied in small aliquots of 0.25 mL to reduce run-off)

OTHER:
The substance had a density greater than 1.0 g/mL. The 5.0 g/kg dosage was administered at a rate of 0.7 mL/100 mg of bw.

Doses:

- 0.59 g/ kg bw
- 1.0 g/ kg bw
- 1.69 g/ kg bw
- 2.88 g/ kg bw
- 5.0 g/ kg bw

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: 1-2, 3-4, 4-5 and 24 hours after dosing and twice daily during the remainder of the 14- day observation period
- Necropsy of survivors performed: yes
- Clinical signs including body weight : Clinical signs were observed during the 14-d observation period, at the end of the 14- day observation period the rats were weighed.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred

Clinical signs:

other: No signs

Gross pathology:

At termination, gas in the intestines was observerd in most of the males and a few females. No other gross pathology was noted.

Applicant's summary and conclusion

Interpretation of results:

other: not harmful

Remarks:

in accordance with EU CLP (EC no 1272/2008 and its amendments)

Conclusions:

Not harmful. The dermal LD50 value of the substance was found to be greater than 5.0 g/kg bw day in both sexes tested using a method similar to OECD 402.

Executive summary:

The dermal LD50 determination in male and female Sprague-Dawley derived albino rats of the substance was performed. Groups of ten male and ten female Sprague-Dawley rats received a single dermal dosage of the substance dissolved in a diluent. Dosages were 0.59, 1.0, 1.69, 2.88 and 5.0 g/kg bw day. All animals were observed for mortality and signs of toxicity. At the end of the 14-day observation period, the rats were weighed and sacrificed. Results showed that there was no mortality, and no clinical signs were observerd during the 14-day observation period. At termination, gas in the intestines was observed in most of the males and a few females. No other gross pathology was noted. All rats gained weight during the observation period. The dermal LD50 value of the substance was found to be greater than 5.0 g/kg bw day in both sexes. Based on this result, the substance is not harmful in accordance with EU CLP (EC no 1272/2008 and its amendments).