Registration Dossier

Administrative data

Description of key information

In studies for skin and eye irritation, no adverse effects were observed for rabbits.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Principles of method if other than guideline:
Study performed according to internal company standards (BASF-test) before actual guideline was adopted.
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: unspecified amount
- Concentration: 100 % (undiluted)
Duration of treatment / exposure:
1, 5, 15 min and 20 hours (ear: only 20 hours)
Observation period:
24, 48, 72 hours, 6 days and 8 days after beginning of application (exception: application time 20 hours: no observations after 24 hours)
Number of animals:
2 (1, 5 and 15 min); 2 (20 hours)
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm area of skin on the back and the ear
- % coverage: not specified (application site 2.5 x 2.5 cm)
- Type of wrap if used: cotton pad soaked with the undiluted test substance, covered by an impervious bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water, sometimes containing a mild detergent
- Time after start of exposure: 1, 5, 15 min, 20 hours (after the application)

SCORING SYSTEM: BASF scoring system, convertible to Draize
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effect
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effect
Irritant / corrosive response data:
After 1, 5, 15 min of exposure, no signs of irritation (erythemy, edema) were apparent after 24, 48 and 72 hours and after 6 and 8 days. After 20 hours of exposure no signs of irritation (erythema, edema) were apparent after 48 and 72 hours and after 6 and 8 days
Other effects:
No mortality occurred. There were no clinical signs of systemic toxicity from the dermal exposure.

No individual animal scores given in the report

Interpretation of results:
not irritating
Remarks:
Migrated information
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
limited documentation
Principles of method if other than guideline:
Study performed according to internal company standards (BASF-test) before actual guideline was adopted.
GLP compliance:
no
Species:
rabbit
Strain:
not specified
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
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 hours
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 8 days
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

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.

Interpretation of results:
not irritating
Remarks:
Migrated information
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin:

The irritation potential of an unspecified dose of undiluted methanol in rabbits was examined under occlusive conditions after exposure intervals of 1, 5, and 15 minutes and 20 hours. According to Draize scoring, no signs of skin irritation were observed 24 hours and 8 days after treatment for any of the exposure time periods (BASF, 1975).

Eye:

One hour after instillation of 0.05 mL undiluted methanol into the eyes of two rabbits, slight erythemas and corneal opacity as well as moderate edemas associated with secretion were observed. After 24 hours, the effects were assessed as mild, and after 8 days the animals had no symptoms (BASF, 1975).

In another study, mild to moderate conjunctivitis and edemas as well as mild iritis were produced in six rabbits after instillation of 0.1 mL undiluted methanol into the eyes. Average scores after 24, 48, and 72 hours were approximately 2 for conjunctivae and < 1 for other effects. Primary irritation subsided after 72 hours, although redness of the conjunctivae persisted at that time. Information on effects after 8 and 14 days was not available (Jacobs, 1990).

Exposure of rats to an atmosphere saturated by methanol vapours at 20 °C produced severe irritation of mucous membranes and milky corneal opacity (time not specified) and eventually led to mortality of all animals within 8 hours (BASF, 1975). This was an additional observation and is not applicable for evaluation of irritant effects. Therefore, it is not relevant for classification.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. No skin or eye irritation was observed. As a result the substance is not considered to be classified for acute oral toxicity under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.