Butyl glycollate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

February 1968

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Sufficient data for assessment considering the date of study report

Cross-reference

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

1968

Report date:

1968

Materials and methods

Test guideline

Test guideline 1

Qualifier:

no guideline available

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

Observation period only 7 days

Principles of method if other than guideline:

LD50 calculated according to the method of Kaerber

GLP compliance:

no

Remarks:

Study performed prior to implementation of GLP

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Butyl glycollate

EC Number:

230-991-7

EC Name:

Butyl glycollate

Cas Number:

7397-62-8

Molecular formula:

C6H12O3

IUPAC Name:

butyl glycolate

Constituent 2

Reference substance name:

Polysolvan O

IUPAC Name:

Polysolvan O

Constituent 3

Reference substance name:

Glycolic acid-n-butyl ester

IUPAC Name:

Glycolic acid-n-butyl ester

Details on test material:

- Name of test material (as cited in study report): Polysolvan O (butyl glycollate)
- Physical state: liquid
- Analytical purity: =97 % (Sum of Glycolic acid-n-butylester, Butoxyacetic acid-n-butylester, Diglycolic acid-di-n-butylester calculated as Glycolic acid-n-butylester)
- Impurities (identity and concentrations): chloro acetic acid n-butyl ester (>0.3% ), glycolic acid (>0.3%), water (>0.3), n-butanol (max. 2%)

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 94 - 124 g (mean 108 g)
- Fasting period before study: 12 h
- Housing:
- Diet: ad libitum (Altromin R, company Altromin, Lage, Germany, exception fasting period)
- Water: tap water ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: sesame oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 25%

Doses:

2500, 4000, 5000, 6300, 10000 mg/kg bw

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 7 days
- Necropsy of survivors performed: yes

Statistics:

None required

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

4 595 mg/kg bw

Mortality:

2500 mg/kg bw: 0/10
4000 mg/kg bw: 2/10
5000 mg/kg bw: 7/10
6300 mg/kg bw: 10/10
10000 mg/kg bw: 10/10

Deaths occurred within 1 - 24 hours after application

Clinical signs:

other: Apathy prior to deaths

Gross pathology:

No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Executive summary:

In an acute oral toxicity study, groups of fasted female Wistar rats (10/group) received a single oral dose of Polysolvan O (butyl glycollate, 97%) as 25% solution in sesame oil at dose levels of 2500, 4000, 5000, 6300, 10000 mg/kg bw and were observed for 7 days. The LD50 was determined according to the method of Kaerber.

 

Beside apathy prior to deaths, there were no treatment related clinical signs and no findings at necropsy. Deaths occurred within 1 – 24 hours and were restricted to the dose levels of 4000 mg/kg bw and above. None of the animals died at 2500 mg/kg bw, a dose level above the current requirement for a limit dose.

 

LD₅₀-value was 4595 mg/kg bw

 

Thus, Polysolvan O (butyl glycollate, 97%) is of low acute oral toxicity based on the LD₅₀value.

Classification and labelling is not required.

 

Conclusion:

Polysolvan O (butyl glycollate, 97%) was tested for acute oral toxicity in a valid test comparable to OECD Guideline No. 401. The oral LD50 value was 4595 mg/kg bw in female Wistar rats.