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EC number: 203-788-6 | CAS number: 110-65-6
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
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- Toxicological Summary
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- Acute Toxicity
- Irritation / corrosion
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- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
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- Additional toxicological data

Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22 Jan 1985 to 12 Feb 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- non-standard rabbit used
- GLP compliance:
- not specified
Test material
- Reference substance name:
- But-2-yne-1,4-diol
- EC Number:
- 203-788-6
- EC Name:
- But-2-yne-1,4-diol
- Cas Number:
- 110-65-6
- Molecular formula:
- C4H6O2
- IUPAC Name:
- but-2-yne-1,4-diol
- Details on test material:
- - Name of test material (as cited in study report): 1,4-Butindiol fest
- Physical state: solid
- Analytical purity: >99%
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Russian, white Chbb-SPF
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Fa. Dr. Karl Thomae GmbH, Biberach
- Age at study initiation: no data
- Weight at study initiation: 2.1 (female) and 2.4 kg (male)
- Diet (e.g. ad libitum): K4 Alleindiät für kaninchen, ad libitum
- Water (e.g. ad libitum): tap, ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20
- Humidity (%): 60
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- Eyes were not rinsed after application. Water-soluble solid.
- Observation period (in vivo):
- 21 days. Observations made at 1, 24, 48, and 72 hours; and 6, 8, 10, 14, 17 and 21 days after application.
- Number of animals or in vitro replicates:
- 6 (3 males / 3 females)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): not done
SCORING SYSTEM: Draize, et. al.
TOOL USED TO ASSESS SCORE: no data
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal 1
- Time point:
- other: 24 to 72 hours
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Remarks on result:
- other: male
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal 2
- Time point:
- other: 24 to 72 hours
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- other: male
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal 3
- Time point:
- other: 24 to 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- other: male
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal 4
- Time point:
- other: 24 to 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- other: female
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal 5
- Time point:
- other: 24 to 72 hours
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- other: female
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal 6
- Time point:
- other: 24 to 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- other: female
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animals 1 and 3
- Time point:
- other: 24 to 72 hours
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: males. No effects on iris observed in either animal during any time period.
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animals 2, 4, and 5
- Time point:
- other: 24 to 72 hours
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- other: Mean score was 0.7 for each of the 3 animals individually, 1 male and 2 females.
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal 6
- Time point:
- other: 24 to 72 hours
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- other: female
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animals 1, 2, 4, and 5.
- Time point:
- other: 24 to 72 hours
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- other: Mean score was 2.3 for each of the 4 animals individually, 2 males and 2 females.
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal 3
- Time point:
- other: 24 to 72 hours
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- other: male
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal 6
- Time point:
- other: 24 to 72 hours
- Score:
- 2.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: female
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animals 1 and 2
- Time point:
- other: 24 to 72 hours
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: males
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animals 3, 4, and 5
- Time point:
- other: 24 to 72 hours
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: 1 male and 2 females
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal 6
- Time point:
- other: 24 to 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: female
- Other effects:
- In two animals, iris turned red in parts. In two other animals, iris turned completely red.
Any other information on results incl. tables
Reading |
Animal |
Cornea |
Iris |
Conjunctiva Redness |
Conjunctiva Chemosis |
1 hour |
1/2/3/4/5/6 |
1/1/1/1/1/1 |
0/0/0/0/0/0 |
2/2/2/2/2/2 |
2/2/2/2/2/2 |
24 hours |
1/2/3/4/5/6 |
1/2/2/2/1/2 |
0/1/0/1/1/1 |
3/3/2/3/3/3 |
1/1/1/1/1/2 |
48 hours |
1/2/3/4/5/6 |
2/1/2/2/1/2 |
0/1/0/1/1/1 |
2/2/2/2/3/3 |
1/1/0/0/0/1 |
72 hours |
1/2/3/4/5/6 |
2/1/2/2/0/2 |
0/0/0/0/0/1 |
2/2/1/2/1/2 |
0/0/0/0/0/0 |
Mean, each animal |
1/2/3/4/5/6 |
1.7/1.3/2.0/ 2.0/0.7/2.0 |
0.0/0.7/0.0/0.7/0.7/1.0 |
2.3/2.3/1.7/2.3/2.3/2.7 |
0.7/0.7/0.3/0.3/0.3/1.0 |
Mean, all animals |
---- |
1.6 |
0.5 |
2.3 |
0.6 |
- In two animals, iris turned red in parts. In two other animals, iris turned completely red.
- For 3 female and 1 of the male test animals, all effects on the cornea reversed within 6 days.
- For 2 male test animals, effects on the cornea were slower to reverse and, in 1 male, did not reverse within the 21 day observation period.
Applicant's summary and conclusion
- Interpretation of results:
- other: Category I (irreversible effects on the eye)
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- 1,4-Butynediol should be regarded as an eye irritant capable of causing irreversible effects on the eye based on 1 of 3 males and 0 of 3 female rabbits with a mean cornea score during the 24 to 72 hour time period of 2.0 that did not reverse within 21 days. No secondary infection was reported in the study. Cornea scores for 5 of the 6 test animals were >1, which further supports classification as an eye irritant.
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