Reaction product of 2,3-epoxypropyl neodecanoate and Benzenesulfonic acid, C10-13-sec-alkyl derivatives

Acute Toxicity: oral

Administrative data

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

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

Test material

Test material information

Constituent 1

Reference substance name:

Reference substance 001

Cas Number:

None

Molecular formula:

C10-13H21-27-C6H4-SO2-O-CH2-C(H)OH-CH2-CO2-C9H19

Test material form:

liquid

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

Test animals

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

Administration / exposure

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

Results and discussion

Preliminary study:

Not performed

Effect levels

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:

other: No signs of toxicity occurred at any dose level

Gross pathology:

No abnormalities were noted at necropsy

Other findings:

None

Any other information on results incl. tables

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	-

Applicant's summary and conclusion

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.