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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting 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-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
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

Reference
Name:
Unnamed
Type:
Constituent
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
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
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:
Migrated information 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.