Registration Dossier

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Study period:
1962
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Older study widely cited for acute toxicity endpoints on many chemicals. Methods suffiently desribed to be considered reliable.

Data source

Reference
Reference Type:
publication
Title:
Range-finding toxicity studies: List VI
Author:
Smyth H.F., et al.,
Year:
1962
Bibliographic source:
American Industrial Hygiene Association Journal 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:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male
Details on test animals and environmental conditions:
Body weight: 2.5-3.5 kg

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24 hours
Doses:
Unspecified
No. of animals per sex per dose:
4 males per group
Control animals:
no
Details on study design:
Animals were immobilised for the 24 hour exposure. Mortality was followed for 14 day follow up period.

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
10 mL/kg bw
95% CL:
6.8 - 14.8

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
The LD50 was estimated to be 10 mL/kg, which is non-hazardous according to the EU and GHS criteria. As DPM has greater skin penetration rate compared with the tripropylene glycol monomethyl ether, this result is expected to adequately represent the acute dermal toxicity hazard of the reaction mass substance submitted for REACH registration.
Executive summary:

Dipropylene glycol monomethyl ether (DPM) was tested for acute dermal toxicity in the male rabbit with a 24-hour occlusive dermal exposure followed by a 14-day follow up period. The LD50 was estimated to be 10 mL/kg (9510 mg/kg).