Reaction mass of 2-methylbutyl salicylate and pentyl salicylate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1981

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Pentyl salicylate

EC Number:

218-080-2

EC Name:

Pentyl salicylate

Cas Number:

2050-08-0

Molecular formula:

C12H16O3

IUPAC Name:

Pentyl 2-hydroxybenzoate

Constituent 2

Reference substance name:

2-methylbutyl salicylate

EC Number:

256-972-3

EC Name:

2-methylbutyl salicylate

Cas Number:

51115-63-0

Molecular formula:

C12H16O3

IUPAC Name:

2-methylbutyl 2-hydroxybenzoate

Test material form:

liquid

Specific details on test material used for the study:

- Name of test material (as cited in study report): PENTYL-2- HYDROXYBENZOAT
- Structural formula attached as image file (if other than submission substance): see Fig.
- Physical state: Liquid
- Storage condition of test material: Room temperature

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Five animals (3 Males and 2 Females) were found dead 1 to 3 days after treatment.

Doses:

Range finder: 5000mg/kg bw, 2000mg/kg bw, 200 mg/kg and 20mg/kg bw
Main study: 2000mg/kg bw

No. of animals per sex per dose:

Ranger finder: 1 male and 1 female per dose level
Main study: 10 males and 10 females per dose level.

Control animals:

no

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 2 000 mg/kg bw

Based on:

test mat.

Clinical signs:

other: Clinical observations Signs of toxicity noted were hunched posture, lethargy and pilo-erection. Additional or isolated signs of toxicity were decreased respiratory rate, ataxia, red/brown staining around the snout and eyes, dehydration, ptosis and tiptoe

Gross pathology:

Necropsy
Abnormalities noted at necropsy of animals that died during study were haemorrhagic or abnormally red lungs, dark or pale liver, pale spleen, haemorrhage of the glandular gastric epithelium, sloughing of the non-glandular gastric epithelium and haemorrhage of the small intestine.
Abnormalities noted at necropsy of animas that were killed at the end of the study included pale liver, adhesion of the stomach to the liver and multiple white foci approximately 2mm x 2mm over 75% of the non-glandular epithelium of the stomach.
No abnormalities were noted at necropsy of the three remaining animals that were killed at the end of the study.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The acute oral median lethal dose (LD50) of the test material in Sprague Dawley strain rat was considered to be approximately 2000mg/kg body weight.

Executive summary:

A study was performed to determine the acute oral median lethal dose (LD50) of the test material, administered as a solution in arachis oil B.P in the Sprague-Sawley strain rat. The method used followed that described in the OECD Guideline for Testing of Chemicals (1981) No, 401 "Acute Oral Toxicity".

Following a range finding study, a group of ten fasted animals (five males and five females) was given a single oral dose of test material preparation at a dose level of 2000mg/kg bw.

Five animals (three males and two females) were found dead one to three days after treatment. Signs of toxicity noted were hunched posture, lethargy and pilo-erection. Additional or isolated signs of toxicity noted were ptosis, red/brown staining around the snout and eyes, ataxia, dehydration, tiptoe gait and decreased respiratory rate. Surviving animals appeared normal four days after treatment.

Incidents of reduced gain in bodyweight and body loss were noted during the study period.

Abnormalities noted at necropsy of animals that died during the study were haemorrhagic or abnormally red lungs, dark or pale liver, pale spleen, haemorrhage of the glandular gastric epithelium, sloughing of the non-glandular gastric epithelium and haemorrhage of the small intestine.

Abnormalities noted at necropsy of animals that were killed at the end of the study included included pale liver, adhesion of the stomach to the liver and multiple white foci approximaely 2mm x 2mm over 75% of the non-glandular epithelium of the stomach.

No abnormalities were noted at necropsy of the three remaining animals that were killed at the end of the study.

The acute oral median lethal dose (LD50) of the test material, HR 90/660541, to the Sprague Dawley strain rat was considered to be approximately 2000mg/kg bw.