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Administrative data

Description of key information

An acute oral toxicity study is available for the submission substance [reaction product of 2,3-epoxypropyl neodecanoate and benzenesulfonic acid,

C10-13-sec-alkyl derivatives]

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
26 July - 12 September 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
Version / remarks:
03 October 2008
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
up-and-down procedure
Specific details on test material used for the study:
IC-2 [Reaction product of 2,3-epoxypropyl neodecanoate and benzenesulfonic acid, C10-13-sec-alkyl derivatives]
Batch P718261998
97.7% purity
Brown / yellow liquid
Expiry 01 June 2018
Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Envigo UK
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8-12 weeks
- Weight at study initiation: not reported, variation +/- 20%
- Fasting period before study: 3-4 hours
- Housing: individual
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30/70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Route of administration:
oral: gavage
Vehicle:
arachis oil
Remarks:
dose level of 2000 mg/kg bw was administered unchanged; arachis oil was used for the 175 and 300 mg/kg bw dose levels
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 17.5 or 55 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw (2000 mg/kg bw dose level)
- Justification for choice of vehicle: based on solubility of the test material

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
Doses:
175, 500, 2000 mg/kg bw
No. of animals per sex per dose:
1 (175 and 550 mg/kg bw); 3 (2000 mg/kg bw)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observations, weekly weighing
- Necropsy of survivors performed: yes
Statistics:
The LD50 was calculated by the mamxium likelihood method
Preliminary study:
Not performed
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No deaths occurred in this study
Mortality:
No deaths occurred at any dose level
Clinical signs:
No signs of toxicity occurred at any dose level
Body weight:
Bodyweights were unaffected by treatment
Gross pathology:
No abnormalities were noted at necropsy
Other findings:
None

Summary of findings

Dose level

Number of rats

Mortality

Clinical signs

175 mg/kg bw

1

0/1

-

550 mg/kg bw

1

0/1

-

2000 mg/kg bw

3

0/3

-

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
The acute oral LD50 of the test material was found to be >2000 mg/kg bw under the conditions of this study. Reaction product of 2,3-epoxypropyl neodecanoate and benzenesulfonic acid, C10-13-sec-alkyl derivatives does not therefore require classification for acute oral toxicity according to the CLP criteria.
Executive summary:

The acute oral toxicity of the substance [reaction product of 2,3-epoxypropyl neodecanoate and benzenesulfonic acid, C10-13-sec-alkyl derivatives] was investigated in a GLP- and Guideline-compliant Up and Down study (OECD 425). Groups of one female SD rat were sequentially gavaged with the test material (in arachis oil) at 175 and 500 mg/kg bw/d. A further three female rats were gavaged with the undiluted test material at a dose level of 2000 mg/kg bw. Rats were observed for 14 days. There was no mortality and no signs of systemic toxicity were observed in the study. Bodyweights were unaffected by treatment and gross necropsy did not reveal any abnormalities. The acute oral LD50 of the test material was therefore found to be >2000 mg/kg bw under the conditions of this study.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
A modern, GLP- and guideline-compliant study is available for the submission substance

Additional information

The acute oral toxicity of the substance [reaction product of 2,3-epoxypropyl neodecanoate and benzenesulfonic acid, C10-13-sec-alkyl derivatives] was investigated in a GLP- and Guideline-compliant Up and Down study (OECD 425). Groups of one female SD rat were sequentially gavaged with the test material (in arachis oil) at 175 and 500 mg/kg bw/d. A further three female rats were gavaged with the undiluted test material at a dose level of 2000 mg/kg bw. Rats were observed for 14 days. There was no mortality and no signs of systemic toxicity were observed in the study. Bodyweights were unaffected by treatment and gross necropsy did not reveal any abnormalities. The acute oral LD50 of the test material was therefore found to be >2000 mg/kg bw under the conditions of this study.

Justification for classification or non-classification

The acute oral LD50 was found to be >2000 mg/kg bw under the conditions of this study.  Reaction product of 2,3-epoxypropyl neodecanoate and benzenesulfonic acid, C10-13-sec-alkyl derivatives does not therefore require classification for acute oral toxicity according to the CLP criteria.