Poly[oxy(methyl-1,2-ethanediyl)], .alpha.-[2-[[2,2-dimethyl-3-[(1-oxododecyl)oxy]propylidene]amino]methylethyl]-.omega.-[2-[[2,2-dimethyl-3-[(1-oxododecyl)oxy]propylidene]amino]methylethoxy]-

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2004-09-10 - 2004-10-13

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:

February 24th 1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

Decembre 29th 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:

Wistar

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: less than ten weeks old
- Weight at study initiation: male: 248 - 255g; female: 172 - 190g
- Housing: individual caging (1 animal/cage)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 13 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): 8 - 12
- 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: trunk of the animals
- % coverage: approximately 10%
- Type of wrap if used: plastic wrap

REMOVAL OF TEST SUBSTANCE
- Washing: with body temperature water
- Time after start of exposure: 24 h

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

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 animals/sex

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations were done once each day, weighing was done on day 0, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

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:

No mortality occurred.

Clinical signs:

other: In male and female animals of 2000 mg/kg bw dose level all treated animals were symptom-free during the study. During the observation period the behaviour and general state of animals were normal.

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 animals.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the findings on the present study, a single 24-hour dermal administration did not induce any test item related adverse effects and a LD50 > 2000 mg/kg bw was derived.

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 semi-occlusive 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 14 days 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. The acute dermal LD50 value is above 2000 mg/kg bw in male and female CRL: (WI) BR rats.