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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:
key study
Study period:
From 1984-03-26 To 1984-07-30
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was performed according to OECD guideline 405 and GLP but is used in read across based on grouping of substances.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material: metiloil A
- Physical state: yellow liquid
- Storage condition of test material: at room temperature
- Composition of test material, percentage of components: mixture of methylesters of satured and insatured C16 to 18 fatty acids, no data.
- Lot/batch No.: 1169
- Acid number: 7 mgKOH/g

Test animals / tissue source

Species:
rabbit
Strain:
other: New Zealand White: Hy/Cr
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River France (76410 Saint Aubin les Elbeuf, france)
- Age at study initiation: no data
- Weight at study initiation: 2.4 kg +/- 0.1 kg
- Housing: individually in polystyrene cage (35.0 x 55.0 x 32.0 cm)
- Diet: rabbit diet SQC (Special diets Services Ltd, Witham, Essex, England), ad libitum
- Water: filtered water with 0.22 µm Millipore membrane (Millipore, 67120 Molsheim, France), ad libitum
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +/- 3°C
- Humidity (%): 50 % +/- 20 %
- Air changes (per hr): no data (filtered air)
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light

IN-LIFE DATES: From: 1984-05-18 To: 1984-05-20

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: right eye
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml

Duration of treatment / exposure:
not rinsed

Observation period (in vivo):
3 days

Number of animals or in vitro replicates:
6

Details on study design:
REMOVAL OF TEST SUBSTANCE: not rinsed

SCORING SYSTEM: similar to grading of ocular lesion described in 405 OECD guideline.


Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Remarks on result:
other: no effect
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72h
Score:
0.16
Max. score:
3
Reversibility:
fully reversible within: 1 day
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72h
Score:
0
Max. score:
2
Remarks on result:
other: no effect
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72h
Score:
0
Max. score:
4
Remarks on result:
other: no effect
Irritant / corrosive response data:
Conjunctivae effects were observed 1 hour after exposure. Slight chemosis and slight conjunctivae were observed in two animals and four animals, respectively. Two animals presented conjunctivae with diffuse, crimson colour and individual vessels not easily discernible. These effects were fully reversible within 1 day.
Other effects:
No data

Any other information on results incl. tables

Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point/ Reversibility  Cornea
Max. score: 4
Iris
Max. score: 2
Conjunctivae
Max. score: 3
Chemosis
Max. score: 4
60 min 0/0/0/0/0/0 0/0/0/0/0/0 2/1/1/1/1/2 0/0/0/1/1/0
24 h 0/0/0/0/0/0 0/0/0/0/0/0 1/0/0/1/0/1 0/0/0/0/0/0
48 h 0/0/0/0/0/0 0/0/0/0/0/0 0/0/0/0/0/0 0/0/0/0/0/0
72 h 0/0/0/0/0/0 0/0/0/0/0/0 0/0/0/0/0/0 0/0/0/0/0/0

Average 24h, 48h, 72h

0 0 0.16 0
Reversibility*) - - c. c.

*) Reversibility: c.=completely reversible; n.c.= not completely reversible; n= not reversible

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: EU-GHS
Conclusions:
Metiloil A was not considered to be an eye irritant.
Executive summary:

In a primary eye irritation study (Kaysen A., 1984), 0.1 ml of Metiloil A (batch No. 1169) was instilled into the conjonctival sac of 6 New Zealand white male rabbits. Animals then were observed for 3 days. Slight irritation was observed one hour after treatment. Slight chemosis and slight conjunctivae were observed in two animals and four animals, respectively. Two animals presented conjunctivae with diffuse, crimson colour and individual vessels not easily discernible. Effects were reversible within one day. In this study, Metiloil A was not considered as an eye irritant based on EU-GHS.