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Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study was conducted prior to GLP and test guidelines, but sufficient data is available for interpretation of results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-methoxy-1-methylethyl acetate
EC Number:
203-603-9
EC Name:
2-methoxy-1-methylethyl acetate
Cas Number:
108-65-6
Molecular formula:
C6H12O3
IUPAC Name:
2-methoxy-1-methylethyl acetate
Details on test material:
- Name of test material (as cited in study report): Dowanol PM Acetate (Propylene Glycol Methyl Ether Acetate or 1-methoxy-2-propanol acetate)
- Physical state: Clear liquid
- Analytical purity:
- Impurities (identity and concentrations):
- Composition of test material, percentage of components:
Propylene Glycol Methyl Ether Acetate
Secondary Isomer - 95.21%
Primary Isomer - 4.59%
Propylene Glycom Methyl Ether
Secondary Isomer - 0.17%
Primary Isomer - 0.07%
Water - 0.046%
Acetic acid - 0.0156%
- Lot/batch No.: DPC 203-92 #3

Test animals

Species:
rabbit
Strain:
other: New Zealand albino
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMAL
Animal care facility was accredited by the American Association for Accreditation of Laboratory Animal Care
- Source: Langshaw Farms, Augusta, Michigan
- Age at study initiation: not specified
- Housing: Rabbits were housed singly
- Diet (e.g. ad libitum): Commercial laboratory chow (Ralston Purina Company, St. Louis, Missouri) ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 week


ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12-hour light and dark cycle


Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Twenty-four hours prior to application of the test material, the entire trunk of 2 male and 2 female rabbits was clipped free of hair with electric clippers. The undiluted test material was applied under a heavy-gauge SARAN film sleeve which was held in place with rubber bands. The plastic sleeve was covered by cloth bandage taped securely to the marginal hair. After 24 hours, the sleeves were removed, and the skins were washed with a mild soap and water, rinsed thoroughly and dried with a soft disposable towel. The rabbits were immediately fitted with a plastic collar to prevent them from ingesting any residue of the material which may still be present after washing. The collars were removed at least 72 hours later. The topical response at the site of application was evaluated after removal of the plastic sleeve.


Duration of exposure:
24 hours
Doses:
5000 mg/kg
No. of animals per sex per dose:
2 males and 2 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed frequently during exposure and the following two weeks for signs of toxicity. Body weights were recorded before and after the 24 hour exposure period and at 1 and 2 weeks post treatment
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 5 000 mg/kg bw
Mortality:
No mortality
Clinical signs:
Topical responses observed when the sleeves of test rabbits were removed included very slight (3/4) erythema and slight (1/3) edema. All rabbits were lethargic following dosage
Body weight:
No treatment related changes were observed. Animal gained body weight post treatment.
Gross pathology:
No treatment related lesions were observed upon gross pathological examination of all rabbits at 2 weeks following treatment.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
As the LD50 value was greater than 5000 mg/kg, the test material is not classified according to EU criteria.
Executive summary:

A sample of Dowanol* PM Acetate also known as Propylene Glycol Methyl Ether Acetate and identified as DPC 203-92 # 3 was submitted for acute percutaneous absorption testing. Male and femalealbino rabbits were used in the study.

 

Twenty-four hours prior to application of the test material, the entire trunk of 2 male and 2 female rabbits/dose level (5000 mg/kg) was clipped free of hair with electric clippers. The undiluted test material was applied under a heavy-gauge SARAN film sleeve which was held in place with rubber bands. The plastic sleeve was covered by cloth bandage taped securely to the marginal hair. After 24 hours, the sleeves were removed, and the skins were washed with a mild soap and water, rinsed thoroughly and dried with a soft disposable towel. The rabbits were immediately fitted with a plastic collar to prevent them from ingesting any residue of the material which may still be present after washing. The collars were removed at least 72 hours later. The topical response at the site of application was evaluated after removal of the plastic sleeve.

 

The animals were observed frequently during exposure and the following 2 weeks for signs of toxicity. Body weights were recorded before and after the 24 hour exposure period and at 1 and 2 weeks post treatment. All rabbits were submitted for a gross pathological examination 2 weeks post treatment.

 

The acute percutaneous absorption LD50 was >5000 mg/kg. Topical responses observed when the sleeves of test rabbits were removed included very slight (3/4) erythema, slight (1/3) edema. All rabbits were lethargic following dosage. No treatment-related lesions were observed upon gross pathological examination of all rabbits at 2 weeks following treatment. As a result test material is not classified according to EU criteria.