2,3-dichlorobuta-1,3-diene

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

March 1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The redacted report is unsigned, the study was conducted prior to introduction of GLP or test guidelines, the details of the method of assessment of reactions are not given, the results appended to the first page are for a different study in a different test species. No results are available to support the report conclusion.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

Materials and methods

Test guideline

Test guideline 1

Qualifier:

no guideline available

Test guideline 2

Deviations:

yes

Remarks:

No method for assessing dermal changes is detailed. The animals were assessed 4, 24 and 48 hours after initial application whereas current test guidelines require a Draize system assessment one hour after removal of the dresssing and at 24, 48 and 72 hrs

Principles of method if other than guideline:

0.5mL test material was applied to clipped regions of the back of 6 albino rabbits. The treated area (circa 4 x 4 cm) was covered with a 12-ply gauze pad and an occlusive dressing for 4 hours. Skin reactions were evaluated after removal of the dressing and 24 and 48 hours later.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Butadiene,2-3-dichloro-/methylene chloride (50/50)

IUPAC Name:

Butadiene,2-3-dichloro-/methylene chloride (50/50)

Details on test material:

Haskell Number 8667, other codes LRT 215.

Test animals

Species:

rabbit

Strain:

other: albino

Details on test animals or test system and environmental conditions:

Albino rabbits weighing between 2-3 kg at time of dosing.

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

0.5 mL of the test material was applied (unchanged).

Duration of treatment / exposure:

After four hours, the rabbits were removed from the stocks, the dressings were removed and the skin was washed.

Observation period:

Any skin reactions were evaluated at the completion of the four hour exposure, and again at 24 and 48 hours after the initial application.

Number of animals:

Six albino rabbits.

Details on study design:

Six albino rabbits were clipped free of hair on their back and placed in FDA-type stocks. 0.5 mL of the test material was applied under a 1.5 by 1.5 inch, 12-ply cotton gauze pad and the trunk of each rabbit was then loosely wrapped with rubber sheeting.

Results and discussion

In vivo

Results

Irritation parameter:

other: corrosion

Basis:

other: reactions in group of six rabbits

Max. score:

0

Reversibility:

no data

Irritant / corrosive response data:

None of the rabbits showed evidence of skin corrosion.

Other effects:

No other effects recorded.

Any other information on results incl. tables

According to the regulations of the Department of Transportation, butadiene, 2-3-dichloro-/methylene chloride (50/50) is not considered a corrosive material.

Applicant's summary and conclusion

Interpretation of results:

other: not corrosive

Remarks:

Criteria used for interpretation of results: other: US department of Transport

Conclusions:

According to the regulations of the Department of Transportation (Hazardous Materials Regulation Board, Docket No. HM-57, Federal Register, Vol. 38, No. 28, Section 173.240, Feb 12 1973) butadiene, 2-3-dichloro-/methylene chloride (50/50) is not considered corrosive material.

Executive summary:

According to the regulations of the Department of Transportation (Hazardous Materials Regulation Board, Docket No. HM-57, Federal Register, Vol. 38, No. 28, Section 173.240, Feb 12 1973) butadiene, 2-3-dichloro-/methylene chloride (50/50) is not considered corrosive material..