Dodecanoic acid, 2,2-dimethyl-3-oxopropyl ester

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2004-09-14 to 2004-09-29

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

24 February 1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Version / remarks:

31 July 1992

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

468-880-2

EC Name:

-

Cas Number:

102985-93-3

Molecular formula:

C17H32O3

IUPAC Name:

2,2-dimethyl-3-oxopropyl dodecanoate

Test material form:

liquid

Test animals

Species:

rat

Strain:

other: CRL (WI) BR Wistar rats

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: CHARLES RIVER (EUROPE) LABORATORIES INC.
- Age at study initiation: young adult rats, less than 10 weeks old
- Weight at study initiation: male: 248 - 255 g, female: 172 - 190 g
- Housing: Individual caging (1 animal/cage)
- Acclimation period: 13 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 8 - 12
- Photoperiod (hrs dark / hrs light): 12 hours daily, from 6.00 a.m. to 6.00 p.m.

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: trunk
- % coverage: 10 per cent of the total body surface
- Type of wrap: plastic wrap

REMOVAL OF TEST SUBSTANCE
- Washing: water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Constant volume or concentration used: yes

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 animals per sex and per dose.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Animals were observed for a 14 days post-treatment observation period. The body weights of animals were recorded on day 0 (beginning of the experiment), at day 7 and at day 14 with precision of 1 g.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, pathology

Statistics:

Not applicable.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None.

Clinical signs:

other: None.

Gross pathology:

In the male dose group of 2000 mg/kg bw, emphysema (4/5 male, 3/5 female) and pinprick-sized haemorrhages (1/5 male 2/5 female) were observed in the lungs. No macroscopic alterations due to the toxic effect of the test item were found. The pulmonary emphysema and the pinprick-sized haemorrhages observed during the necropsy might be related to the method of anaesthesia and are also observed in untreated (control) animals.

Other findings:

None.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the study results the acute dermal median lethal toxicity (LD50) of Aldhyd L in Wistar rat was considered to be greater than 2000 mg/kg bw.

Executive summary:

The acute dermal toxicity study (Limit Test) according to OECD 402 was performed with 2,2-Dimethyl-3-lauroyloxy-propanal. Five male and 5 female CRL (WI) BR Wistar rats were treated (single 24-hour dermal application) with undiluted 2,2-Dimethyl-3-lauroyloxy-propanal at a dose level of 2000 mg/kg bw. None of these animals died. Clinical signs or dermal symptoms were not observed during the 14days post-treatment observation period. No effects on mean body weight and body weight gain were noted for these dose groups. Specific macroscopic alterations related to the toxic effect of the test item 2,2-Dimethyl-3-lauroyloxy-propanal were not found. Based on the results of this test, the acute dermal LD50 of 2,2-Dimethyl-3-lauroyloxy-propanal was estimated to be greater than 2000 mg/kg bw in the rat.