Registration Dossier

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:
No data
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study was conducted according to GLP and sufficient data is available for interpretation of results.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Untreated DPE 75 (XZ 95510)
- Distillate containing 75% diphenylethane (DPE)
- Physical state: Clear, very pale straw-colored liquid
- Storage condition of test material: Room temperature
-Source: Dow Chemical Europe S.A.

Test animals

Species:
rat
Strain:
other: Sprague Dawley CFY
Sex:
male
Details on test animals and environmental conditions:
Sprague Dawley CFY rats obtained from Interfauna (UK) Limited, Wyton, Huntingdon, Cambridgeshire, were used.

The animals were housed in groups of three in solid floor polypropylene cages furnished with softwood sawdust. The animal room temperature was maintained at 19 to 25°C with 40 to 70% relative humidity. Artificaial lighting provided 12 hours light and 12 hours darkness. The animals were acclimatised for at least three days before treatment and individually identified by ear punching and cage card. The animals had free access to food (Rat and Mouse Expanded Diet No. 1, Special Diet Services Limited, Witham, Essex, UK). Water was provided at all times from glass water bottles.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Four groups, each of three male rats were given a single 24-hour, occluded dermal application to the shaved back at dose levels of 0.05, 1.0, 2.0 or 4.0 ml/kg or g/kg. Liquid testmaterial was used undiluted. The test site was covered with aluminium foil and secured by adhesive tape.
Duration of exposure:
24 hours
Doses:
0.05, 1.0, 2.0 or 4.0 ml/kg
No. of animals per sex per dose:
3 male rats/dose
Control animals:
no
Details on study design:
Four groups, each of three male rats were given a single 24-hour, occluded dermal application to the shaved back at dose levels of 0.05, 1.0, 2.0 or 4.0 ml/kg or g/kg. Liquid testmaterial was used undiluted. The test site was covered with aluminium foil and secured by adhesive tape.

Animals were observed for overt systemic toxicity and mortality one and four hours after dosing and then at least once daily for seven days. Individual bodyweights were recorded on the day of treatment. No necropsies were performed.

Using the mortality data an estimate of the acute dermal LD50 of the test material was made.
Statistics:
None

Results and discussion

Preliminary study:
No data
Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 4 mL/kg bw
Mortality:
No mortality
Clinical signs:
Animals treated with 4.0 ml/kg showed signs of toxicity on the day of dosing including lethargy, decreased respiratory rate, vocalisation, increased lacrimation and red/brown staining around the eyes and snout. All animals in the 2.0 m l /kg dose group showed lethargy and vocalisation at the one hour observation and vocalisation was also noted in one animal treated with 1.0 ml/kg one and four hours after treatment.

Hunched posture, pilo-erection and decreased respiratory rate persisted in the animals from the 4.0 ml/kg dose group on days one and two. Vocalisation was also apparent in one of these animals on day one. Animals in this group recovered to appear normal on day three and the affected animals from the other groups appeared normal four hours after treatment or on day one. No further signs of toxicity were noted during the study period. There was no evidence of systemic toxicity in animals treated with 0.5 ml/kg.


Body weight:
No data
Gross pathology:
No data
Other findings:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The estimated acute dermal LD50 in the male rat following a single, 24 hour, occluded application to intact skin was greater than 4.0 ml/kg.
Executive summary:

Untreated DPE 75 (75% diphenyl ethane), a potential thermal oil, was provided for toxicity, testing by the Olefin Derivatives Department, DCE. It was tested for oral and dermal toxicity in groups of 3 male rats. Administration of up to 4.0 ml/kg dermally resulted only in non-specific signs of treatment which were absent after 3 days.

Skin irritation studies were performed with 3 New Zealand White rabbits in each case. A 4 hour dermal application of 0.5 ml/kg resulted in erythema and oedema in all rabbits which lasted for more than 3 days but had recovered by 7 days.

Untreated DPE75 has very low toxicity by dermal routes.