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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From July 28 to August 14, 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
1987
Deviations:
yes
Remarks:
highest temperature recorded was 26 °C
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Esterification products of acrylic acid with reaction products of 2,2-dimethylpropane-1,3-diol and methyloxirane
EC Number:
701-440-2
Molecular formula:
(C3H6O)x (C3H6O)y C11H16O4
IUPAC Name:
Esterification products of acrylic acid with reaction products of 2,2-dimethylpropane-1,3-diol and methyloxirane
Test material form:
liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan U.K. Ltd, Oxon, England.
- Age at study initiation: Approximately 5-7 weeks
- Weight at study initiation: 122-149 g
- Fasting period before dosing: Overnight
- Fasting period after dosing: 4 h
- Housing: Up to 5 rats/sex in metal cages
- Diet: Standard laboratory rodent diet (Special Diet Services RM1(E) SQC expanded pellet), ad libitum
- Water: Drinking water, ad libitum
- Acclimation period: 15 days

ENVIRONMENTAL CONDITIONS
- Temperature: 21-26 °C
- Humidity: 39-58 %
- Photoperiod: 12 h dark / 12 h artificial light

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 3.147 mL/kg bw in preliminary study and 4.916 mL/kg bw in main study
- DOSAGE PREPARATION: Test substance was administered as supplied (specific gravity 1.017).
- Rationale for the selection of the dosage for main study: Dose was selected based on preliminary study conducted on 1 rat/sex/dose at 3200 mg/kg bw and animals were observed for 7 days.
Doses:
- Preliminary study: 3200 mg/kg bw
- Main study: 5000 mg/kg bw
No. of animals per sex per dose:
- Preliminary study: 1
- Main study: 5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality: At least twice daily
Clinical signs: Animals were observed soon after dosing and at frequent intervals for the remainder of Day 1; subsequently twice daily for 14 days, with the exception of the day of study termination (Day 15)-morning only.
Bodyweight was recorded on Days 1 (prior to dosing), 8 and 15 for main study.
- Necropsy of survivors performed: Yes, all animals were killed by carbon dioxide asphyxiation at study termination (Day 15). All animals were subjected to a macroscopic examination.
Statistics:
None

Results and discussion

Preliminary study:
- No mortality was observed.
- Clinical signs: Piloerection, hunched posture, pallid extremities, increased salivation, abnormal faeces and ungroomed appearance, seen in both rats.
- Bodyweight gain for both rats was considered satisfactory.
- No macroscopic abnormalities were observed in either animal at the terminal necropsy on Day 8.
Effect levels
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed at 5000 mg/kg bw.
Clinical signs:
other: - Piloerection was observed in all rats within 4 minutes of dosing. This sign persisted and was accompanied in rats later on Day 1 and/or at later intervals during the study by increased salivation, abnormal faeces and ungroomed appearance, seen in all ra
Gross pathology:
- No macroscopic abnormalities were observed at necropsy.
Other findings:
None

Any other information on results incl. tables

Table 1: Signs of reaction to treatment

 

Signs of reaction

No. of rats in group of 1 * or

5 per sex showing signs

Dose (mg/kg bw)

3200*

5000

Male

Female

Male

Female

Piloerection

1

1

5

5

Hunched posture

1

1

0

0

Pallid extremities

1

1

0

0

Increased salivation

1

1

5

5

Abnormal faecesa

1

1

5

5

Ungroomed appearanceb

1

1

5

5

 

* Preliminary studies comprised one male and one female

a Characterised by soft to liquid faeces

b Characterised by soiled/stained fur around face/muzzle or ano/genital region or wet fur

 

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The oral LD50 for SR 9003 is greater than 5000 mg/kg bw in rats as no mortality was observed at this dose level.
Executive summary:

In an acute oral toxicity study (limit test) performed according to OECD Guideline 401 and in compliance with GLP, groups (5/sex) of CD rats of Sprague Dawley origin [Hsd:Sprague-Dawley (CD)] were given a single oral dose of Propoxylated neopentylglycol diacrylate (SR 9003) at 5000 mg/kg bw. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and were all sacrificed for macroscopic examination. A preliminary study was also conducted on 1 rat/sex/dose at 3200 mg/kg bw and animals were observed for 7 days.

 

In the preliminary study, no mortality was observed. Piloerection, hunched posture, pallid extremities, increased salivation, abnormal faeces and ungroomed appearance seen in both rats. Bodyweight gain for both rats was considered satisfactory. No macroscopic abnormalities were observed in either animal at the terminal necropsy on Day 8. In the main study, no mortality was observed. Piloerection was observed in all rats within 4 minutes of dosing. This sign persisted and was accompanied in rats later on Day 1 and/or at later intervals during the study by increased salivation, abnormal faeces and ungroomed appearance, seen in all rats. There were no other signs of reaction to treatment and recovery was complete in all instances by Day 4. Bodyweight gain was considered satisfactory in all rats throughout the study. No macroscopic abnormalities were observed for animals killed at study termination on Day 15. In this study, the combined oral LD50 of Propoxylated neopentylglycol diacrylate (SR 9003) was considered to be greater than 5000 mg/kg bw.

  

The oral LD50 for Propoxylated neopentylglycol diacrylate (SR 9003) is greater than 5000 mg/kg bw in rats therefore it is not classified according to the Annex VI to the Directive 67/548/EEC and the CLP Regulation (EC) N° (1272-2008).