Registration Dossier

Administrative data

Description of key information

1-Methylimidazol was found to be corrosive to the rabbit skin under occlusive conditions. A single application of undiluted 1-methylimidazol to the rabbit eye caused cauterization of the mucous membranes.

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:
guideline study with acceptable restrictions
Remarks:
pre-GLP, pre-OECD guideline, occlusive exposure for 1, 5, 15 min and 20 h, observation period 8 days.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
Method: BASF-Test: Animals were treated for 1, 5, 15 min and 20 hours using occlusive conditions. An application site of 2.5x2.5 cm was covered with the liquid test substance. After the application time (1, 5, 15 min and 20 hours) the skin was washed with Lutrol (50%). The animals were observed for 8 days and skin changes were recorded daily. The report describes findings after 24 hours and at the end of the observation period (8 days). For a final evaluation, the findings after 48 h and 72 h from the raw data were taken into account.
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
no
Duration of treatment / exposure:
1, 5 , 15 min and 20 h
Observation period:
8 d
Number of animals:
2
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm (patch test)

REMOVAL OF TEST SUBSTANCE
- After the application time the skin was washed with Lutrol (50%).
Irritation parameter:
erythema score
Remarks:
1 min of exposure
Basis:
mean
Time point:
other: 24 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: scaling (scoring after 8 days not possible)
Irritation parameter:
erythema score
Remarks:
5 min of exposure
Basis:
mean
Time point:
other: 24 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: necrosis (scoring after 8 days not possible), hardening of the skin
Irritation parameter:
erythema score
Remarks:
15 min of exposure
Basis:
mean
Time point:
other: 24 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: severe necrosis (scoring after 8 days not possible)
Irritation parameter:
erythema score
Remarks:
20 h of exposure
Basis:
mean
Time point:
other: 24 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: severe necrosis (scoring after 8 days not possible), scarring of the skin
Irritation parameter:
edema score
Remarks:
1 min of exposure
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
4
Remarks on result:
other: scaling (scoring after 8 days not possible)
Irritation parameter:
edema score
Remarks:
5 min of exposure
Basis:
mean
Time point:
other: 24 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: necrosis (scoring after 8 days not possible), hardening of the skin
Irritation parameter:
edema score
Remarks:
15 min of exposure
Basis:
mean
Time point:
other: 24 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: severe necrosis (scoring after 8 days not possible)
Irritation parameter:
edema score
Remarks:
20 h of exposure
Basis:
mean
Time point:
other: 24 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: severe necrosis (scoring after 8 days not possible), scarring of the skin
Interpretation of results:
corrosive
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

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:
pre-GLP, pre-OECD guideline, 50 µl amount of test substance, 8 days observation period.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
Method: BASF-Test: 50 µL of the test substance were applied to the conjunctival sac of one eye in 2 animals. The animals were observed after 10 min, 1 and 3h on the day of treatment and up to 8 days afterwards. Findings were recorded daily. The eyes were not washed out after 24 hours as specified in OECD Guideline 405. The report describes findings after 1 and 24 hours and at the end of the observation period. For final evaluation, the findings after 48 and 72 hours from the raw data were taken into account.
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.05 ml
Duration of treatment / exposure:
single application, no washing was performed
Observation period (in vivo):
8 d
Number of animals or in vitro replicates:
2
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
Irritation parameter:
cornea opacity score
Basis:
other: animal #1 and #2
Time point:
other: 1 h - 24 h - 8 d
Score:
1 - 2
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: cauterization at all time points
Irritation parameter:
conjunctivae score
Basis:
other: animal #1 and #2
Time point:
other: 8 d
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: cauterization at all time points
Irritation parameter:
chemosis score
Basis:
other: animal #1 and #2
Time point:
other: 1 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: cauterization at all time points
Irritation parameter:
iris score
Basis:
other: animal #1 and #2
Time point:
other: 24 h - 8 d
Score:
0
Max. score:
2
Remarks on result:
other: cauterization at all time points
Irritant / corrosive response data:
Cauterization of the mucous membrane was observed at all time points.
Interpretation of results:
corrosive
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

1-Methylimidazol was applied to the skin of Vienna White rabbits in a study according to the internal standard (which is comparable to OECD guideline 404) for 1, 5 and 15 min and 20 h (using 2 animals at all exposure durations) under occlusive conditions and observed for 8 days (1966). Erythema and edema scores of 2 - 3 were reported at 24 hours after the treatment. Scoring at 8 days was not possible. Application caused (severe) necrosis, scarring of the skin and hardening of the skin after 5, 15 min and 20 h of exposure. 1-Methylimidazol was judged corrosive to the skin.

 

Eye irritation

1-Methylimidazol was applied to the conjunctival sac of the eyes of 2 Vienna White rabbits in a study according to the internal standard (which is comparable to OECD guideline 405) (1966). Animals were observed 1 hour, 24 hours and 8 days after installation. The application caused cauterization of the mucous membrane of the eyes at all time points. 1-Methylimidazol was judged corrosive to the eyes.

Justification for classification or non-classification

Based on the available data, 1-methylimidazol needs to be classified as corrosive to the skin and eyes according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 (Category 1B, H314).