Registration Dossier
Registration Dossier
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EC number: 229-222-8 | CAS number: 6440-58-0
Endpoint summary
Administrative data
Description of key information
DMDMH readily undergoes hydrolysis to DMH and therefore data is provided for both substances. DMDMH gives rise to only slight irritation. DMH gives rise to no more than slight irritation.
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
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-5 (Acute Dermal Irritation)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days
- Number of animals:
- 3 males and 3 females
- Details on study design:
- TEST SITE
- Area of exposure: one 6cm2 dose site.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Water
- Time after start of exposure: 4 hours - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24/48/72 hours
- Score:
- 0.73
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24/48/72 hours
- Score:
- 0.2
- Reversibility:
- fully reversible within: 72 hours
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Glycoserve II is considered to be non irritating to the skin (not classified)
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-4 (Acute Eye Irritation)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.1 ml of Glycoserve II equivalent to 52.6 mg of DMDMH
- Duration of treatment / exposure:
- Not applicable
- Observation period (in vivo):
- 4 days
- Number of animals or in vitro replicates:
- Six (3 males and 3 females)
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24/48/72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable since no cornea effect
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24/48/72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable since no iris effect
- Irritation parameter:
- other: conjunctivae - redness
- Basis:
- mean
- Time point:
- other: 24/48/72 hours
- Score:
- 0.5
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- other: conjunctivae - chemosis
- Basis:
- mean
- Time point:
- other: 24/48/72 hours
- Score:
- 0.33
- Reversibility:
- fully reversible within: 4 days
- Irritant / corrosive response data:
- No corneal or iritis were noted during the study. Conjunctivitis was exhibited in all rabbits.
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Glycoserve II is considered to be minimally irritating (not classified)
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
DMDMH is slightly irritating to the skin and eye. DMH is not irritating to the skin but slightly irritating to the eye.
Justification for selection of skin irritation / corrosion endpoint:
Only one study available on DMDMH. The study is Klimisch 1.
Justification for selection of eye irritation endpoint:
Only one study available on DMDMH. The study is Klimisch 1.
Justification for classification or non-classification
The degree of irritancy observed is insufficient to meet the classification criteria and hence DMDMH is not classified for skin or eye irritancy.
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