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Administrative data

Description of key information

DMDMH readily undergoes hydrolysis to DMH and therefore data is provided for both substances. DMDMH is of low  to moderate acute toxicity and DMH is of low acute toxicity.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Qualifier:
according to
Guideline:
EPA OPP 81-1 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
500, 2320, 3410 and 5000mg/kg
No. of animals per sex per dose:
5 animals per sex per dose
Control animals:
no
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 890 mg/kg bw
Based on:
test mat.
Mortality:
At 500 mg/kg - 0/10
At 2320 mg/kg - 1/10
At 3410 mg/kg - 8/10
At 5000 mg/kg - 9/10
Clinical signs:
Clinical changes noted during the observation period included ataxia, saliva and fecal stains, piloerection, shallow and gasping breathing, slight to severe depression, reddish stains around the eyes and on muzzle and dirty hair coats.
Gross pathology:
The gross necropsy findings in the animals that died were those generally seen in agonal animals. In the animals which survived there were no gross pathological findings.
Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 (rat, oral) for Glycoserve II - 2890mg/kg
Executive summary:

The LD50 (rat, oral) for Glycoserve II = 2890mg/kg, equivalent to LD50 (rat; oral) for DMDMH - 1572mg/kg.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
1 572 mg/kg bw
Quality of whole database:
Sufficient to meet data requirements. The study is Klimisch 1.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available
Quality of whole database:
An acute inhalation toxicity study is scientifically unjustified and is not in the interests of animal welfare. Acute studies are available by the oral and dermal routes.

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Qualifier:
according to
Guideline:
EPA OPP 81-2 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no
Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- % coverage: 10%
- Type of wrap if used: Occlusive

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Water
- Time after start of exposure: 24 hrs

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.6 ml/kg b.w.



Duration of exposure:
24 hours
Doses:
2000mg/kg/bw of Glycoserve II equivalent to 1052 mg DMDMH/kg/bw
No. of animals per sex per dose:
5/sex/group
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Examinations: Gross toxicity including gross evaluation of the skin, fur, eyes and mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity and behaviour pattern
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
None
Gross pathology:
None
Other findings:
Erythema, edema and eschar were present at dose site
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 value for the Glycoserve II is > 2000 mg/kg, equivalent to >1052 mg/kg DMDMH
Executive summary:

The LD50 value for the Glycoserve II (52,6% DMDMH in aqueous solution) is higher than 2000 mg/kg b.w., equivalent value for the active substance (DMDMH) is 1052 mg/kg b.w.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
1 052 mg/kg bw
Quality of whole database:
Sufficient to meet data requirements. The study is Klimisch 1.

Additional information

DMDMH is of low to moderate acute toxicity in mammals. The acute oral LD50 is reported in two different studies as 1572 and 2046 mg/kg respectively while the dermal LD50 is above 1052 mg/kg. Testing by the inhalation route is not scientifically justified.

The hydrolysis product DMH is of low acute toxicity in mammals. The acute oral LD50 is 10000 - 20000 mg/kg and the dermal LD50 is above 20000 mg/kg.


Justification for selection of acute toxicity – oral endpoint
Two studies available on DMDMH. This study is the more reliable and gave the lower dose descriptor.

Justification for selection of acute toxicity – dermal endpoint
Only one study available on DMDMH.

Justification for classification or non-classification

Given the acute oral LD50 values, DMDMH is classified for acute toxicity by the oral route. Following dermal dosing at up to 1052 mg/kg no mortalities or signs of systemic toxicity were seen. Given that signs of toxicity were seen at 1/5th of the LD50 value in the acute oral study, it is concluded that the dermal LD50 lies significantly above 2000 mg/kg and hence classification is not justified for the dermal route.