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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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: Federal Register 38 No 187 § 1500.41 ( Haut) und § 1500.42 (Auge), S. 27019 vom 27.09.73 .
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Pentane-1,5-diol
EC Number:
203-854-4
EC Name:
Pentane-1,5-diol
Cas Number:
111-29-5
Molecular formula:
C5H12O2
IUPAC Name:
pentane-1,5-diol
Details on test material:
- Name of test material (as cited in study report): 1,5-pentanediol

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): 100%
Duration of treatment / exposure:
one application
Observation period (in vivo):
8 d
Number of animals or in vitro replicates:
2 male, 4 female
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing

TOOL USED TO ASSESS SCORE: fluorescein

SCORING SYSTEM:
Conjunctival redness, chemosis and corneal opacity were scored according to the below described system.
Although the results in the report were originally not given as Draize scores the data can be transferred into the Draize scoring system (in brackets). (+) = none - negligible effect (Draize score 0)
+ = slight effect (1)
++ = moderate effect (2)
+++ = severe effect (> = 3)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
0.2
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
1.4
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
0.6
Max. score:
4
Reversibility:
fully reversible

Any other information on results incl. tables

Results:

Animal 1: female, 3.11 kg

Animal 2: female, 3.12 kg

Animal 3: male, 2.93 kg

Animal 4: male, 2.99 kg

Animal 5: female, 2.81 kg

Animal 6: female, 3.30 kg

Readings Animal cornea Iris conjunctiva Symptons
opacity area redness swelling discharge
1 h 1 1 4 0 2 2 2  
2 1 4 0 2 2 2  
3 1 4 0 2 2 2  
4 1 4 0 2 2 2  
5 1 4 0 2 2 2  
6 1 4 0 2 2 2  
24 h 1 1 4 0 2 1 1  
2 1 4 0 2 1 1  
3 1 4 0 2 2 1  
4 1 4 1 2 2 2  
5 1 4 0 2 1 1  
6 1 4 0 2 1 1  
48 h 1 1 4 0 2 1 1 sc
2 1 3 0 1 0 1  
3 1 4 1 1 1 1 sc
4 1 4 0 1 0 1  
5 1 3 0 1 0 1  
6 1 2 0 1 0 1  
72 h 1 1 4 0 1 0 1 sc
2 1 3 0 1 0 0  
3 1 4 1 1 0 1 sc
4 1 4 0 1 0 1  
5 1 3 0 1 0 1  
6 1 2 0 1 0 1  
8 d 1 1 3 0 1 0 0 sc
2 0 0 0 0 0 0  
3 0 0 0 0 0 0 sc
4 0 0 0 0 0 0  
5 0 0 0 0 0 0  
6 0 0 0 0 0 0  
mean 24 - 72 h 1 1.0 4.0 0.0 1.7 0.7 1.0  
2 1.0 3.3 0.0 1.3 0.3 0.7  
3 1.0 4.0 0.7 1.3 1.0 1.0  
4 1.0 4.0 0.3 1.3 0.7 1.3  
5 1.0 3.3 0.0 1.3 0.3 1.0  
6 1.0 2.7 0.0 1.3 0.3 1.0  
mean 24 - 72 h 1 - 6 1.0 3.6 0.2 1.4 0.6 1.0

sc: scar

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU