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EC number: 203-924-4 | CAS number: 111-96-6
Toxicological information
Acute Toxicity: dermal
Currently viewing:
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1981
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study according to OECD402; no individual data reported
- Justification for type of information:
- Diethylene glycol dimethylether and 1,2-Diemethoxyethane which is tested for its acute inhalation toxicity, belong to the glycol ether family. These substances have been demonstrated to be very similar in structure, physical/chemical properties and the toxicological profile. Due to the fact that diethylene glycol dimethylether and 1,2-Diemethoxyethane have nearly the same chemical structure (especially with reference to the functional groups):
1. Diethylene glycol dimethyl ether: H3C-O-CH2-CH2-O-CH2-CH2-O-CH3
2. 1,2-Diemethoxyethane: H3C-O-CH2-CH2-O-CH3
the same mode of interaction with living cells and tissue is expected based in the same metabolism. Within metabolism, the active metabolite 2-methoxyethanol is formed for both substances. This metabolite is driving force behind the toxicological profile of both substances. Therefore, a read-across from diethylene glycol dimethylether to data obtained with 1,2-Diemethoxyethane is scientifically justified.
Cross-reference
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- acute toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1981
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study according to OECD402; no individual data reported
- Justification for type of information:
- Diethylene glycol dimethylether and 1,2-Diemethoxyethane which is tested for its acute inhalation toxicity, belong to the glycol ether family. These substances have been demonstrated to be very similar in structure, physical/chemical properties and the toxicological profile. Due to the fact that diethylene glycol dimethylether and 1,2-Diemethoxyethane have nearly the same chemical structure (especially with reference to the functional groups):
1. Diethylene glycol dimethyl ether: H3C-O-CH2-CH2-O-CH2-CH2-O-CH3
2. 1,2-Diemethoxyethane: H3C-O-CH2-CH2-O-CH3
the same mode of interaction with living cells and tissue is expected based in the same metabolism. Within metabolism, the active metabolite 2-methoxyethanol is formed for both substances. This metabolite is driving force behind the toxicological profile of both substances. Therefore, a read-across from diethylene glycol dimethylether to data obtained with 1,2-Diemethoxyethane is scientifically justified. - Reason / purpose for cross-reference:
- assessment report
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- only one sex tested, limitations in study reporting
- Principles of method if other than guideline:
- acute dermal toxicity after single application
- GLP compliance:
- no
- Remarks:
- performed before GLP guidelines
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG, Kastengrund, SPF breed
-Strain: Hoe WISKf(SPF71)
- Age at study initiation: no data
- Weight at study initiation: 170 - 176 g (female animals); (mean = 172,7 g; s = ± 2,42; n = 6)
- Diet (e.g. ad libitum): Altromin 1324 ad libitum
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Housing: single, in plastic cages, softwood pellets - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 30 cm2
- % coverage: 100
- Type of wrap if used: aluminium foil (6 x 8 cm) fixed with elastic bandage (Elastoplast, 8 cm)
REMOVAL OF TEST SUBSTANCE
- Washing. lukewarm water
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied: 500 mg/kg bw undiluted test substance was applied - Duration of exposure:
- 24 hours
- Doses:
- 5000 mg/kg body weight
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical observation after application; weighing once weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, mortality - Preliminary study:
- no preliminary study performed
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- No mortality
- Clinical signs:
- other: No clinical symptoms detectable.
- Gross pathology:
- No macroscopic visible changes.
- Other findings:
- No further findings.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The median lethal dose (LD50) of diethylenglykol dimethylether was derived from the structural analogue supporting substance monoethylene glycol dimethyl ether to be greater 5000 mg/kg body weight in female rats.
- Executive summary:
The median lethal dose (LD50) of diethylenglykol dimethylether was derived from the structural analogue supporting substance monoethylene glycol dimethyl ether to be greater 5000 mg/kg body weight in female rats. Therefore, there ist no justifaction for a classification of diethyleneglycol dimethyl ether as acute toxic.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- only one sex tested, limitations in study reporting
- Principles of method if other than guideline:
- acute dermal toxicity after single application
- GLP compliance:
- no
- Remarks:
- performed before GLP guidelines
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Monoethylenglykoldimethylether
- IUPAC Name:
- Monoethylenglykoldimethylether
- Reference substance name:
- 1,2-dimethoxyethane
- EC Number:
- 203-794-9
- EC Name:
- 1,2-dimethoxyethane
- Cas Number:
- 110-71-4
- Molecular formula:
- C4H10O2
- IUPAC Name:
- 1,2-dimethoxyethane
- Details on test material:
- - Name of test material (as cited in study report): Monoethylenglykoldimethylether
- Analytical purity: not stated
- physical state: clear colourless liquid
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG, Kastengrund, SPF breed
-Strain: Hoe WISKf(SPF71)
- Age at study initiation: no data
- Weight at study initiation: 170 - 176 g (female animals); (mean = 172,7 g; s = ± 2,42; n = 6)
- Diet (e.g. ad libitum): Altromin 1324 ad libitum
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Housing: single, in plastic cages, softwood pellets
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 30 cm2
- % coverage: 100
- Type of wrap if used: aluminium foil (6 x 8 cm) fixed with elastic bandage (Elastoplast, 8 cm)
REMOVAL OF TEST SUBSTANCE
- Washing. lukewarm water
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied: 500 mg/kg bw undiluted test substance was applied - Duration of exposure:
- 24 hours
- Doses:
- 5000 mg/kg body weight
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical observation after application; weighing once weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, mortality
Results and discussion
- Preliminary study:
- no preliminary study performed
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- No mortality
- Clinical signs:
- other: No clinical symptoms detectable.
- Gross pathology:
- No macroscopic visible changes.
- Other findings:
- No further findings.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The median lethal dose (LD50) of diethylenglykol dimethylether was derived from the structural analogue supporting substance monoethylene glycol dimethyl ether to be greater 5000 mg/kg body weight in female rats.
- Executive summary:
The median lethal dose (LD50) of diethylenglykol dimethylether was derived from the structural analogue supporting substance monoethylene glycol dimethyl ether to be greater 5000 mg/kg body weight in female rats. Therefore, there ist no justifaction for a classification of diethyleneglycol dimethyl ether as acute toxic.
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