Registration Dossier

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
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Qualifier:
according to
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)
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:
1 (reliable without restriction)
Qualifier:
according to
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)
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.