2-Butyne-1,4-diol, polymer with methyloxirane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: comparable to guideline but non-GLP study; However, lots of parameters are documented in raw data.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

Number of animals

Principles of method if other than guideline:

ln principle, the methods described in OECD Guideline 420 were used.
Deviations: Number of test animals

GLP compliance:

no

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

Oligomerisation products of But-2-yne-1,4-diol and methyloxirane

EC Number:

612-177-7

Cas Number:

61596-96-1

Molecular formula:

(C3 H6 O)m (C3 H6 O)n C4 H6 O2 with 1 ≤ (m+n) ≤ 4.5

IUPAC Name:

Oligomerisation products of But-2-yne-1,4-diol and methyloxirane

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): Butindiol-mono-propylenglykolether
- Lot/batch No.: no data
- Physical state: liquid
- Purity: 100%
- Density: 1.1 kg/m3

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: average weight female: 170 g, average weight male: 250 g
- Diet (e.g. ad libitum): yes, Altromin R1324 (Altromin GmbH Lage)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 2,15% - 4,64%
- Amount of vehicle (if gavage): 10ml
- Justification for choice of vehicle: common vehicle
- Purity: 100%

MAXIMUM DOSE VOLUME APPLIED:

Doses:

464 mg/kg, 316 mg/kg, 215 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 15 minutes, 30 minutes, 1h, 2h, 4h, 5h, 1day - 14 days
- Other examinations performed: clinical signs, body weight, gross pathology

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 250 other: µl/kg bw

Based on:

test mat.

Remarks on result:

other: purity 100%

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 275 mg/kg bw

Based on:

test mat.

Remarks on result:

other: purity 100%

Mortality:

There were deaths among all doses:

Death/total
Concentration Male Female
4.64% 5/5 5/5
3.16% 3/5 4/5
2.15% 2/5 2/5

Clinical signs:

other: - respiratory distress - apathy - in part: abdominal position - ataxia - spastic gait - diarrhea - exsiccosis

Gross pathology:

Heart: acute dilatation and accumulation of blood
Liver: periphere lobular enlargement and soft consistency
Kidney: bright cortex

Applicant's summary and conclusion

Interpretation of results:

Toxicity Category III

Remarks:

Migrated information GHS (EU) Criteria used for interpretation of results: EU

Conclusions:

Acute oral toxicity yields to an LD50 of 275 mg/kg bw and therefore the test substance should be classified as acute oral toxic categorie 3 (GHS) (BASF, 1980)

Executive summary:

ln principle, the methods described in OECD Guideline 420 were used without GLP compliance.

5 rats per sex and dose were treated simultaneously with concentrations of 464 mg/kg, 316 mg/kg, 215 mg/kg by gavage

with preparations of the test substance in water as vehicle.

Group-wise documentation of clinical signs was performed over the 14- day study period, where clinical signs and mortality was documented, which was observed among all doses.

On the basis of the observed lethality, the LD50 value was estimated to be 250µl/kg bw, which is in accordance with 275mg/kg and as a conseqence of it, the test substance should be classified as acute oral toxic categorie 3 (GHS). (BASF, 1976)