Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

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:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Acute toxicity of 1,4-butanediol in laboratory animals.
Author:
Jedrychowski et al.
Year:
1990
Bibliographic source:
Polish Journal of Occupational Mediciene 3, (4), 415 - 420

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Draize, et. al., J Pharm Exp Ther 82. 377-390, 1994
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Butane-1,4-diol
EC Number:
203-786-5
EC Name:
Butane-1,4-diol
Cas Number:
110-63-4
Molecular formula:
C4H10O2
IUPAC Name:
butane-1,4-diol
Details on test material:
purity above 98%

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Four New Zealand White rabbits, housed individually in stainless-steel cages, were used to assess ocular irritation. Food (LSK, Fodder Plant, Motycz, Poland) and water were provided ad libitum.

TEST ANIMALS
- Source: Nofer Institute of Ocupational Medicien husbandry
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: Housed individually in stainless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7-14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-19
- Humidity (%): 55-65
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: No data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animals
Amount / concentration applied:
0.1 ml
Observation period (in vivo):
1, 24, 48 and 72 hrs postdosing
Number of animals or in vitro replicates:
4
Details on study design:
BAD (1,4-butanediol) was administered as a single dose of 0.1 ml, which was placed in the conjunctival sac of the right eye of four rabbits. The unexposed eye of each rabbit served as a concurrent control. The examination for signs of ocular irritation was made at intervals of 1, 24, 48 and 72 hrs postdosing according to the method of Draize et al. A Draize score was computed at each observation time by averaging the total scores of all rabbits tested. For classification the ocular irritation index was computed by averagingg Draize scores at 1, 24, 48 and 72 hrs. Eye irritancy ratings were determined using classification system as folIows: no reaction 0, slightly irritating 1-16, moderately irritating 17 - 35, severaly irritating 36 - 75, extremely irritating 75-110.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1, 24, 48, 72 hours
Score:
0
Max. score:
110
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Remarks on result:
no indication of irritation

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Slight reddening of the conjunctives and small amounts of discharge were observed in all rabbits 1 hr after ocular application of BAD (1,4-butanediol). The changes diminished after 24 and 48 hrs. No abnormalities were observed thereafter.