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Toxicological information

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:
1961
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted prior to Guidelines/GLP. The report contains sufficient information to permit a meaningful evaluation of study results.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1961
Report Date:
1961
Reference Type:
publication
Title:
Range-Finding Toxicity Data: List VI
Author:
Smyth, H.F., Carpenter, C.P., Weil, C.S. et al.
Year:
1962
Bibliographic source:
Published in Am Ind Hyg Assoc J. 23: 95-107.

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no
Test type:
other: Range Finding study
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Monomethyl Ether of Dipropylene Glycol

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: The rabbits were procured locally and maintained on Rockland Rabbit station
- Age at study initiation: 3 to 5 months of age
- Weight at study initiation: 2.5 kg

Administration / exposure

Type of coverage:
not specified
Vehicle:
other: Vinylite sheeting
Details on dermal exposure:
The fur was removed from the entire trunk by clipping and the dose was retained an impervious plastic film (VINYLITE sheeting). Rabbits were immobilizes during the 24-hour skin contact period. Thereafter, VINYLITE sheeting was removed and the animals were caged for the remainder of the 14-day observation period.
Duration of exposure:
24 hour
Doses:
20, 10 and 5 ml/kg
No. of animals per sex per dose:
4 males per dose level
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: No
See the table attached below for more details.
Statistics:
The moving average method of calculating the LD50 was used.

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
10 mL/kg bw
Remarks on result:
other: (6.8-14.8 ml/kg bw)
Sex:
male
Dose descriptor:
LD50
Effect level:
9 510 mg/kg bw
Mortality:
20 ml/kg-4/4
10 ml/kg-2/4
5 ml/kg-0/4
Clinical signs:
Marked erythema of the skin was found upon removal of the impervious plastic covering after the 24-hour contact.
Body weight:
All survivors gained weigt during the two-week holding period.
Gross pathology:
At autopsy, gross observation disclosed some consolidation and congestion of the lungs, dark mottled livers with prominent acini, and very pale smooth-textured kidneys.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material is not classified according to EU criteria as LD50 value is greater than 2000 mg/kg BW.
Executive summary:

Monomethyl ether of Dipropylene Glycol was evaluated for skin penetration in rabbits. Male albinostrain rabbits, three to five months of age and averaging 2.5 kg in weight, were immobilized during the 24-hour skin contact period. Thereafter, the VINYLITE sheeting used to retain the dose in contact with the clipped skin of the trunk was removed and the animals were caged for the remainder of the 14-day observation period. The rabbits were procured locally and maintained onrabbit station. The moving average method of calculating the LD50 was used.

 

Most deaths were delayed from three to four days after dosing. At autopsy, gross observation disclosed some consolidation and congestion of the lungs, dark mottled livers with prominent acini, and very pale smooth-textured kidneys.

 

The LD50 was calculated to be 10.0 (6.8 to 14.8) ml/kg. as received. Marked erythema of the skin was found upon removal of the impervious plastic covering after the 24-hour contact. All survivors gained weight during the two-week holding period. The test material was not classified as toxic according to EU criteria as LD50 was greater than 2000 mg/kg bw.