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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Study period:
10 July - 13 July 1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions (only few data on test substance given)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
only few details on study substance
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Fatty acids, C16-18, triesters with trimethylolpropane
EC Number:
293-037-9
EC Name:
Fatty acids, C16-18, triesters with trimethylolpropane
Cas Number:
91050-90-7
Details on test material:
- Name of test material (as cited in study report): only trade name given
- Physical state: solid, white
- Analytical purity: not reported

Test animals / tissue source

Species:
rabbit
Strain:
other: Kleinrusse, Chbb
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Thomae, Biberach, Germany
- Age at study initiation: 6 months
- Weight at study initiation: 2.6 kg
- Housing: individually in rabbit-battery
- Diet: Altromin 2023 ad libitum
- Water: tap water, ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 45-70
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL (slightly warmed)
Duration of treatment / exposure:
24 h
Observation period (in vivo):
72 h
Reading time points: 1, 24, 48, 72 h
Number of animals or in vitro replicates:
3 males
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, rinsed with water
- Time after start of exposure: 24 h

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of all three animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
of all three animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
not specified
Remarks:
reversibility: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of all three animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
3
Reversibility:
other: reversibility: not applicable
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of all three animals
Time point:
other: 24 h, 48 h and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritant / corrosive response data:
Redness of the conjuctivae of grade 1 was seen in all 3 animals at reading time point 1 h only. In 2 cases this was accompanied by exudation. These effects disappeared within 24 h.

Any other information on results incl. tables

Table 1: Eye irritation scores 

Animal

Hours after application

1

24

48

72

A

B

C

D

E

A

B

C

D

E

A

B

C

D

E

A

B

C

D

E

1

0

0

1

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

2

0

0

1

0

1

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

3

0

0

1

0

1

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

A = Corneal Score

B = Iris Score

C = Erythema Score

D = Chemosis Score

E = Exsudation Score

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified