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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific principles with acceptable restrictions.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1972
Report Date:
1972
Reference Type:
secondary source
Title:
Unnamed
Year:
1972
Report Date:
1972

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
: occlusive conditions for 24 h; no data on body weight, clinical signs and gross pathology.
GLP compliance:
no
Remarks:
; GLP was not compulsory at the time the study was conducted.
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): HDODA SN-1258; 1,6-hexanediol diacrylate
- Analytical purity: no data given

Test animals

Species:
rabbit
Strain:
other: albino
Sex:
not specified
Details on test animals and environmental conditions:
no data

Administration / exposure

Type of coverage:
occlusive
Vehicle:
not specified
Details on dermal exposure:
The animals were prepared by careful removal of the hair with electric clippers. Planned areas of application were identified. After weighing the animal the calculated dose was applied and the entire area covered with rubber dam and held in place by tape.
Duration of exposure:
24 h
Doses:
0.315, 0.795, 1.99 and 5.0 ml/kg bw
No. of animals per sex per dose:
4 animals per dose (only 3 at 1.99 mg/kg bw)
Control animals:
other: the untreated sites of the same animal served as control
Details on study design:
24 h after exposure, the binders were removed and an effort made to remove any remaining material from the skin surface.
A score of the local effects, according to the method of Draize, was recorded. The animals were observed repeatedly for seven days at the end of which time they were sacrificed. Necropsy was performed and samples of any abnormal tissues were preserved in 10 % formalin for possible future histopathologic examination.

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
3 650 mg/kg bw
Remarks on result:
other: original value given as 3.6 ml/kg bw
Mortality:
No deaths occured at doses of 0.315 and 0.795 mL/kg bw. At 1.99 mL/kg bw one animal out of three died and at 5.0 mL/kg bw two out of four animals died.
Clinical signs:
no data given
Body weight:
no data given
Gross pathology:
no data given
Other findings:
The test material produced only slight to moderate erythema and edema and was not scheduled for the primary skin irritation test

Applicant's summary and conclusion