Hydrocarbons, C3

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non-GLP, non-guideline, animal and human experimental study, predates implementation of GLP and/or development of study guidelines but otherwise acceptable for assessment

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

publication

Title:

Studies on the inhalation of 1,3-butadiene; with a comparison of its narcotic effect with benzol, toluol and styrene, and a note on the elimination of styrene by the human

Author:

Carpenter CP, Shaffer CB, Weir CS, Smyth HF

Year:

1944

Bibliographic source:

J Ind Hyg Toxicol 26; 69-78

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

Female dogs and male and female rabbits were exposed to 0, 600, 2300 and 6700 ppm 1,3-butadiene for 8 months (7.5h/day, 6 days/week). Eyes were examined prior to, during and after exposure. Eyes were taken at post mortem and examined histopathologically.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

1,3-Butadiene

Cas Number:

106-99-0

Molecular formula:

C4H6

IUPAC Name:

1,3-Butadiene

Details on test material:

Supplied by: Carbide and Carbon Chemicals Corporation

Test animals / tissue source

Species:

other: Dog and rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

no details available

Test system

Vehicle:

other: air

Controls:

yes

Amount / concentration applied:

Concentrated chemical applied

Duration of treatment / exposure:

8 months

Observation period (in vivo):

8 months

Number of animals or in vitro replicates:

1 female dog/group (4 in total); 2 male and 2 female rabbits/group (8 male and 8 female in total)

Details on study design:

EXPOSURE: Exposure chambers of 546 L capacity, constructed of masonite and coated with a Bakelite varnish were used. The airflow ranged from 100-190 L/min, which resulted in 10-20 complete changes of air/hour. 1,3-Butadiene was metered directly from a cylinder through a reducing valve and capillary flowrneter, and added to the dilution air being drawn into the chamber from the room. The highest concentration used for repeated exposure approximated one-third of the lower explosive limit.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Remarks:

qualitative ophthalmoscopic and histopathological examination

Time point:

other: 8 months

Remarks on result:

other: no signs of irritation in dogs or rabbits, no effects on the cornea, sclera, or ciliary body, no degeneration of the retinal ganglion

Results 2

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Results 3

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Results 4

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Results 5

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Irritant / corrosive response data:

no irritation

Other effects:

none

Any other information on results incl. tables

Ophthalmoscopic examination revealed no signs of irritation in dogs or rabbits. Histopathological examination revealed no effects on the cornea, sclera, or ciliary body. None of the sections showed any indication of degeneration of the retinal ganglion cells, and the other retinal layers displayed no abnormality. Sections of the optic nerve with adjacent retina stained with osmic acid showed no degeneration of myelin sheaths.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

1,3-Butadiene is non irritant to the rabbit and dog eye following exposure to 1,3-butadiene for 8 months at concentrations up to 6700 ppm ( 14824 mg/m3)..

Executive summary:

Dogs and rabbits were exposed to 1,3-butadiene for 8 months at concentrations of 600, 2300 and 6700 ppm (1327, 5098 and 14824 mg/m3) and eyes examined. No irritation to the eyes of the dogs or rabbits occurred at any doses.