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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2004-09-02 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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Version / remarks:
2004
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rat
Strain:
other: CRL (WI) BR Wistar rats
Sex:
female
Details on test animals 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:
Step 1: 163, 174, 175 g before the treatment.
Step 2: 160,160, 163 g before the treatment.
- Housing: Group caging (3 animals/cage)
- Acclimation period: 8 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +- 3 °C.
- Humidity (%): 30-70 %
- Air changes (per hr): 8-12
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: sunflower oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle: 2000 mg/kg bw
- Purity: 96.9 %


Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6 animals per dose, 3 animals/step.
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Aniimals were observed daily for 15 days after dosing. The body weight were measured and recorded on day 0 (beginning of the experiment), on days 7 and 14 with precision of 1 g.
- Necropsy of survivors performed: yes
- Other examinations performed:
clinical signs:
A careful clinical examination was made continuously for 30 minutes after the application, then 1h, 2h, 3h, 4h, 5h after the treatment and once each day for 14 days thereafter. Individual observations were performed on the skin and fur, eyes and mucous membranes, and also respiratory, circulatory, autonomic and central nervous system, somatomotor activity and behaviour pattern.
body weight:
The body weight were measured and recorded on day 0 (beginning of the experiment), on days 7 and 14 with precision of 1 g.
Statistics:
Not applicable.

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
>= 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed.
Clinical signs:
No clinical symptoms appeared after the treatment. The behaviour and general state of all six animals were normal during the study.
Body weight:
The mean body weight and body weight gain of the animals treated with 2000 mg/kg bw 2,2-Dimethyl-3-lauroyloxy-propanal were normal during the two-week observation period, similar to which could be expected in untreated animals of the same age and strain.
Gross pathology:
In the three female animals treated in the first step (2000 mg/kg bw), pulmonary emphysema was observed (No.: 1560, 1561,1562).
In the further three female animals treated at the second step (2000 mg/kg bw), pinprick-sized haemorrhages were found in the lungs (No.: 1563, 1564,1565). In animal No.: 1563, hydrometra occurred, as well.
No macroscopic alterations related to the toxic effect of the test item were found.
The pulmonary emphysema and pinprick-sized haemorrhages in the lungscould be most likely attributed to the terminal procedures. Hydrometra is a common alteration, which occurs sporadically in the experimental rats and was regarded as incidental

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the present study, a single oral administration of the test item 2,2-Dimethyl-3-lauroyloxy-propanal caused neither signs of toxicity nor mortality at 2000 mg/kg bw dose.
Executive summary:

The acute toxic class method according to OECD 423 was performed with 2,2-Dimethyl-3-lauroyloxy-propanal. Six female CRL:(WI) BR Wistar rats were treated with 2,2-Dimethyl-3-lauroyloxy-propanal by oral gavage (single application) at a dose level of 2000 mg/kg in sunflower oil. There was no mortality in the study. Based on these findings no further testing was performed. No clinical signs appeared after administration of 2,2-Dimethyl-3-lauroyloxy-propanal at 2000 mg/kg dose level. No effects on mean body weight and body weight gain were noted for these dose groups. Macroscopic alterations due 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 oral LD50 of 2,2-Dimethyl-3-lauroyloxy-propanal was estimated to be greater than 2000 mg/kg bw in the rat.