Ethanol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

hypothesis As a hypothesis, methanol is the critical constituent of the substance (S-Ethanol, composition 2) based on its amount and with regards to its hazardous properties. It is the major constituent affecting the classification and labeling of the target substance (S-Ethanol). Therefore, data from methanol is used in the read-across approach in order to update the hazard assessment of this substance. Other impurities are taken into account for self-classification but there were no need to consider evaluating their properties in hazard assessment because of low concentrations. Analogue approach justification This substance (S-Ethanol, composition 2) has degree of ethanol purity between 76.4-81.9 %. Methanol is the main impurity of the target substance (conc. 13-14 %), and considered the major driver for adverse effects based on its properties and relative quantity in the substance. For chemical safety assessment certain physico-chemical properties are relevant for both human health and environmental health assessment. Also they are important for self-classification and for updating of the exposure assessment of the target substance. For toxicological endpoints, methanol is considered the major drivers for classification and overall safety assessment of the target substance. Therefore, methanol properties were included for chemical safety assessment and the endpoint robust summaries were provided also for methanol.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Principles of method if other than guideline:

Study performed according to internal company standards (BASF-test) before actual guideline was adopted.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Methanol

EC Number:

200-659-6

EC Name:

Methanol

Cas Number:

67-56-1

Molecular formula:

CH4O

IUPAC Name:

methanol

Details on test material:

- Name of test material (as cited in study report): methanol, not further specified
- Analytical purity: no data

Test animals / tissue source

Species:

rabbit

Strain:

not specified

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: saline-treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.05 ml
- Concentration (if solution): 100 %

Duration of treatment / exposure:

unspecified (not rinsed)

Observation period (in vivo):

1 hour, 24 hours, 8 days (no further time points reported)

Number of animals or in vitro replicates:

2

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not rinsed

SCORING SYSTEM: BASF-code, convertible to DRAIZE

TOOL USED TO ASSESS SCORE: no data

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24 hours

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 8 days

Results 2

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24 hours

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 8 days

Results 3

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24 hours

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 8 days

Irritant / corrosive response data:

After 1 h, mild erythema and cornea opacity as well as moderate edema associated with secretion were observed. After 24 h, the effects were assessed as mild. After 8 days the animals were without symptoms.

Other effects:

not reported

Any other information on results incl. tables

This screening test gave evidence of mild to moderate irritation of the mucous membrane on contact with pure methanol, which was fully reversible within 8 days. Therefore, there was no need for classification as eye irritating.

Exposure to an atmosphere saturated by methanol vapours at 20°C produced severe irritation of mucous membranes and milky corneal opacity in rats (time not specified) and eventually led to mortality of all animals within 8 h.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information