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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
from 1984-03-26 to 1984-07-30
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: 1a : The study was performed according to OECD guideline 405 and GLP.

Data source

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

Materials and methods

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

Test material

Constituent 1
Reference substance name:
Fatty acids, C16-18 and C18-unsatd., Me esters
EC Number:
267-015-4
EC Name:
Fatty acids, C16-18 and C18-unsatd., Me esters
IUPAC Name:
267-015-4
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 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 affeter exposure. Slight chemosis and slight conjunctivae were observed in two animals and four animals, respectively. Two animals presented conjontivae with diffuse, crimson colour and individual vessels not easily discernible. These effects were fully reverdible 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;= 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 yey 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 conjonctivae in two animals and four animals, respectively. Two animals presented concontivae 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 a eye irritant based on EU-GHS.