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EC number: 235-166-5 | CAS number: 12108-13-3
Endpoint summary
Administrative data
Description of key information
Skin irritation
In a reliable study performed similar to OECD 403, the average erythema/eschar score and the edema score were below a score of 2.3 in all animals. Therefore although slight irritation was observed it is insufficient to classify mmt as a skin irritant per EC/1272/2008.
Eye irritation
The key study for this endpoint did not show that mmt would induce effects sufficient for classifiction as an eye irritant per EC/1272/2008. The main observed effect was mild conjunctivae effects with some vessels injected (score 1), in 5 of the 6 animals exposed, and a mild chemosis in one animal (score 1). These effects lasted at maximum 4 days in the animals.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- No data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- environmental conditions not mentioned. Exposure was for 24 hours rater than the recommended time of 4 hours. Skin on two sides of the rabbit is tested, but one of the sides is abraded, testing was not carried out through reversibility (up to 14 days)..
- GLP compliance:
- no
- Remarks:
- Study conducted prior to GLP guidelines.
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Not mentioned
- Age at study initiation: Not mentioned
- Weight at study initiation: 1.9-2.3 kg
- Housing: No data
- Diet: No data
- Water : No data
- Acclimation period: No data
ENVIRONMENTAL CONDITIONS
Not reported.
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: Two sides per rabbit were used, one abraded and other intact.
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): 100% - Duration of treatment / exposure:
- 24 hours.
- Observation period:
- 72 hours in total, with observations recorded at 24 and 72 hours.
- Number of animals:
- 6 Rabbits.
- Details on study design:
- TEST SITE
- Area of exposure: Back and sides, a site to the left of the spinal column was abraded, while a site to the right of the spinal column was left intact.
- % coverage: no data
- Type of wrap if used: Surgical gauze, each site was a 1x1 area, two layers thick.
REMOVAL OF TEST SUBSTANCE
- Washing: No
- Time after start of exposure: N.A.
SCORING SYSTEM: Erythema and eschar formation and edema formation - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.25
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: Intact Skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: abraded skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: abraded skin
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.79
- Max. score:
- 8
- Reversibility:
- not specified
- Remarks on result:
- other: Abraded and intact skin
- Irritant / corrosive response data:
- The raw data is presented in table 1 and table 2 on the field "Remarks on results including tables and figures".
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information mmt is not classified as a skin irritant per EC/1272/2008.
- Conclusions:
- Although the primary dermal index score for mmt was 2.79., neither the erythema/eschar score nor the edema score exceeded the score of 2.3 in any animal. This score is necessary for classification under EC/1272/2008.
- Executive summary:
In a primary dermal irritation study, six New Zealand rabbits were dermally exposed to 0.5 ml of unchanged mmt for 24 hours. Animals were then observed for 72 hours. Irritation was scored by the method of OECD grading of skin reaction.
Although the primary dermal irritation index for erythema and oedema was 2.79, neither the erythema/eschar score nor the edema score exceeded the score of 2.3 necessary for classification under EC/1272/2008.
Reference
Table 1 - Erythema and eschar formation:
|
Exposure time (Hours) |
Rabbit No. |
Mean score |
|||||
|
1 |
2 |
3 |
4 |
5 |
6 |
||
Intact skin |
24 |
2 |
1 |
1 |
2 |
1 |
1 |
1.33 |
Abraded skin |
24 |
1 |
1 |
1 |
2 |
2 |
1 |
1.33 |
Intact skin |
72 |
1 |
2 |
0 |
2 |
1 |
1 |
1.17 |
Abraded skin |
72 |
2 |
2 |
0 |
2 |
1 |
1 |
1.33 |
Table 2 - Edema formation:
|
Exposure time (Hours) |
Rabbit No. |
Mean score |
|||||
|
1 |
2 |
3 |
4 |
5 |
6 |
||
Intact skin |
24 |
2 |
2 |
2 |
2 |
2 |
2 |
2.00 |
Abraded skin |
24 |
2 |
2 |
1 |
2 |
2 |
2 |
1.83 |
Intact skin |
72 |
1 |
2 |
0 |
1 |
1 |
1 |
1.00 |
Abraded skin |
72 |
2 |
2 |
0 |
1 |
1 |
1 |
1.17 |
Total sum of mean score (erythema + edema) = 11.16
Primary Dermal Irritation Index = Sum of Mean Scores/4 = 2.79
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Not mentioned.
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- information on animal husbandry and environmental conditions was not provided.
- GLP compliance:
- no
- Remarks:
- Study conducted prior to GLP guidelines
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Not mentioned
- Age at study initiation: Not mentioned
- Weight at study initiation: 1.9-2.3 kg
- Housing: Individually housed
- Diet : Not mentioned
- Water : Not mentioned
- Acclimation period: Not mentioned - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 ml
- Concentration : 100%
- Duration of treatment / exposure:
- The test substance was administrated to the eye of the rabbit, and not further removed.
- Observation period (in vivo):
- Animals were observed for 7 days post-exposure as symptoms persisted at maximum of 4 days post-dosage.
- Number of animals or in vitro replicates:
- Six rabbits.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: No
- Time after start of exposure: N.A.
SCORING SYSTEM: Check below "Any other information on materials and methods incl. tables".
TOOL USED TO ASSESS SCORE: fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- See Table 1 and Table 2
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- mmt did not produce a response indicative ocular irritation upon direct contact with the eye.
- Executive summary:
In this eye irritation study, 0.1 ml of mmt- technical was instilled into the conjunctival sac of six albino New Zealand rabbits. No effects were observed 7 dayts post exposure , so the study was terminated. Irritation was scored by the method of Draize. The main observed effect was a mild conjunctivae, some vessels injected (score 1), in 5 of the 6 animals exposed, and a mild chemosis in one animal (score 1). The few irritations observed lasted at maximum 4 days in the animals. mmt would not be classified as an eye irritant per EC/1272/2008.
Reference
Table 1 - Individual score for eye irritation
Animals No. |
Time after administration - Days |
Positive score |
||||
1 |
2 |
3 |
4 |
7 |
||
791 |
||||||
1. Cornea |
||||||
A. Opacity |
0 |
0 |
0 |
0 |
0 |
No |
B. Stippling |
0 |
0 |
0 |
0 |
0 |
No |
D. Ulceration |
0 |
0 |
0 |
0 |
0 |
No |
Score |
0 |
0 |
0 |
0 |
0 |
No |
2. Iris |
0 |
0 |
0 |
0 |
0 |
No |
Score |
0 |
0 |
0 |
0 |
0 |
|
3. Conjunctivae |
||||||
A. Redness |
1 |
0 |
0 |
0 |
0 |
No |
B. Chemosis |
1 |
0 |
0 |
0 |
0 |
No |
C. Discharge |
0 |
0 |
0 |
0 |
0 |
|
D. Necrosis Or Ulceration |
0 |
0 |
0 |
0 |
0 |
No |
Score |
4 |
0 |
0 |
0 |
0 |
|
Total score |
4 |
0 |
0 |
0 |
0 |
|
792 |
||||||
1. Cornea |
||||||
A. Opacity |
0 |
0 |
0 |
0 |
0 |
No |
B. Stippling |
0 |
0 |
0 |
0 |
0 |
|
D. Ulceration |
0 |
0 |
0 |
0 |
0 |
No |
Score |
0 |
0 |
0 |
0 |
0 |
|
2. Iris |
0 |
0 |
0 |
0 |
0 |
No |
Score |
0 |
0 |
0 |
0 |
0 |
|
3. Conjunctivae |
||||||
A. Redness |
1 |
1 |
0 |
0 |
0 |
No |
B. Chemosis |
0 |
0 |
0 |
0 |
0 |
No |
C. Discharge |
0 |
0 |
0 |
0 |
0 |
|
D. Necrosis Or Ulceration |
0 |
0 |
0 |
0 |
0 |
No |
Score |
2 |
2 |
0 |
0 |
0 |
|
Total score |
2 |
2 |
0 |
0 |
0 |
|
793 |
||||||
1. Cornea |
||||||
A. Opacity |
0 |
0 |
0 |
0 |
0 |
No |
B. Stippling |
0 |
0 |
0 |
0 |
0 |
|
D. Ulceration |
0 |
0 |
0 |
0 |
0 |
No |
Score |
0 |
0 |
0 |
0 |
0 |
|
2. Iris |
0 |
0 |
0 |
0 |
0 |
No |
Score |
0 |
0 |
0 |
0 |
0 |
|
3. Conjunctivae |
||||||
A. Redness |
1 |
0 |
0 |
0 |
0 |
No |
B. Chemosis |
1 |
0 |
0 |
0 |
0 |
No |
C. Discharge |
0 |
0 |
0 |
0 |
0 |
|
D. Necrosis Or Ulceration |
0 |
0 |
0 |
0 |
0 |
No |
Score |
4 |
0 |
0 |
0 |
0 |
|
Total score |
4 |
0 |
0 |
0 |
0 |
|
794 |
||||||
1. Cornea |
||||||
A. Opacity |
0 |
0 |
0 |
0 |
0 |
No |
B. Stippling |
0 |
0 |
0 |
0 |
0 |
|
D. Ulceration |
0 |
0 |
0 |
0 |
0 |
No |
Score |
0 |
0 |
0 |
0 |
0 |
|
2. Iris |
0 |
0 |
0 |
0 |
0 |
No |
Score |
0 |
0 |
0 |
0 |
0 |
|
3. Conjunctivae |
||||||
A. Redness |
0 |
0 |
0 |
0 |
0 |
No |
B. Chemosis |
0 |
0 |
0 |
0 |
0 |
No |
C. Discharge |
0 |
0 |
0 |
0 |
0 |
|
D. Necrosis Or Ulceration |
0 |
0 |
0 |
0 |
0 |
No |
Score |
0 |
0 |
0 |
0 |
0 |
|
Total score |
0 |
0 |
0 |
0 |
0 |
|
796 |
||||||
1. Cornea |
||||||
A. Opacity |
0 |
|
|
|
|
|
B. Stippling |
0 |
|
|
|
|
|
D. Ulceration |
0 |
|
|
|
|
|
Score |
0 |
|
|
|
|
|
2. Iris |
0 |
|
|
|
|
|
Score |
0 |
|
|
|
|
|
3. Conjunctivae |
||||||
A. Redness |
1 |
1 |
1 |
0 |
0 |
No |
B. Chemosis |
0 |
0 |
0 |
0 |
0 |
No |
C. Discharge |
0 |
0 |
0 |
0 |
0 |
|
D. Necrosis Or Ulceration |
0 |
0 |
0 |
0 |
0 |
No |
Score |
2 |
2 |
2 |
0 |
0 |
|
|
2 |
2 |
2 |
0 |
0 |
|
798 |
||||||
1. Cornea |
||||||
A. Opacity |
0 |
0 |
0 |
0 |
0 |
No |
B. Stippling |
0 |
0 |
0 |
0 |
0 |
|
D. Ulceration |
0 |
0 |
0 |
0 |
0 |
No |
Score |
0 |
0 |
0 |
0 |
0 |
|
2. Iris |
0 |
0 |
0 |
0 |
0 |
No |
Score |
0 |
0 |
0 |
0 |
0 |
|
3. Conjunctivae0 |
||||||
A. Redness |
1 |
1 |
0 |
0 |
0 |
No |
B. Chemosis |
0 |
0 |
0 |
0 |
0 |
No |
C. Discharge |
0 |
1 |
0 |
0 |
0 |
|
D. Necrosis Or Ulceration |
0 |
0 |
0 |
0 |
0 |
No |
Score |
2 |
4 |
0 |
0 |
0 |
|
Total score |
2 |
4 |
0 |
0 |
|
|
Table 2 - Summary of response and Maximum Draize Scores
Positive (+) or Negative (-) Scores |
|||||||
|
Conjunctivae |
|
|||||
Animal Number |
Cornea |
Iris |
Redness |
Chemosis |
Necrosis or Ulceration |
Clear at Day |
Maximum Draize score |
791 |
- |
- |
- |
- |
- |
2 |
2 |
792 |
- |
- |
- |
- |
- |
3 |
2 |
793 |
- |
- |
- |
- |
- |
2 |
4 |
794 |
- |
- |
- |
- |
- |
1 |
0 |
796 |
- |
- |
- |
- |
- |
4 |
2 |
798 |
- |
- |
- |
- |
- |
3 |
4 |
Total |
0 |
0 |
0 |
0 |
0 |
|
14 |
|
Mean: 2 |
||||||
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
Multiple studies and a review article are summarized under this endpoint. The key study showed mild irritation however the severity was insufficient to categorize mmt as irritating based on a mean scores for erythema/eschar or eodema of less than 2.3. Based on the low erythema/aschar and eodema scores, mmt would not be classified as skin irritant per EC/1272/2008. The other studies summarized for this endpoint (supporting or disregarded support this non-classification. The review article indicated that mmt would be classified as a moderate skin irritant based on the Primary Dermal Irritant Index (PDII); however raw values for attaining this score were not available so the data from this source could not be accurately assessed.
Eye irritation
The key study for this endpoint did not show that mmt would induce effects sufficient for classification as an eye irritant per EC/1272/2008. The main observed effect was mild conjunctivae effects with some vessels injected (score 1), in 5 of the 6 animals exposed, and a mild chemosis in one animal (score 1). These effects lasted at maximum 4 days in the animals. Other sources of information summarized in the dataset also indicated that mmt did not elicit eye irritation effects.Justification for selection of skin irritation / corrosion endpoint:
In a reliable study performed similar to OECD 404, the average erythema/eschar score and the edema score were below a score of 2.3 in all animals. Therefore, although slight irritation was observed it is insufficient to classify mmt as a skin irritant per EC/1272/2008.
Justification for selection of eye irritation endpoint:
Reliable study performed similat to OECD 405 with sufficient informartion on materials and methods for assessment. The study showed that mmt is not irritating to the eyes based on the specification of EC/1272/2008.
Effects on skin irritation/corrosion: slightly irritating
Justification for classification or non-classification
mmt is not classified as a skin irritant. In a reliable study performed similar to OECD 404, the average erythema/eschar score and the edema score were below a score of 2.3 in all animals required for classification. Therefore, although slight irritation was observed it is insufficient to classify mmt as a skin irritant per EC/1272/2008.
mmt is not irritating to the eyes based on the study 4184 -76 performed by Biodynamics, and further supported by publications of the University of Cincinnati and EPA.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
