Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

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:
11 Jan - 11 Mar 1999
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP - Guideline study. According to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OTS 798.4500 (Acute Eye Irritation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: M.A.F.F. No. 4200 (1985)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Glycerides, C16-18 mono- and di-
EC Number:
286-490-9
EC Name:
Glycerides, C16-18 mono- and di-
Cas Number:
85251-77-0
Molecular formula:
C19H38O4, C21H42O4, C35H68O5, C39H76O5
IUPAC Name:
Glycerides, C16-18 mono- and di-
Details on test material:
- Name of test material (as cited in study report): only trade name given
- Physical state: white powder
- Analytical purity: considered as 100 % for the study
- Batch no.: 21150
- Storage conditions: at room temperature
- Expiry date: 2000-08-01
- Other: pH = 5.8;
- Other: volumetric mass = 0.54 g/mL

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Elevage Scientifique des Dombes, Chalaronne, France
- Age at study initiation: about 3 months
- Weight at study initiation: 2.38-2.66 kg
- Housing: barrier protected unit, individually in stainless steel cages
- Diet: about 150 g/animal/day pelleted complete rabbit diet 112 C-10 (Usine d'Alimentation Rationnelle, Epinay-sur-Orge, France)
- Water: softened and filtered mains drinking water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 ± 3
- Humidity (%): > 45%
- Air changes (per hr): min. 12
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 25 Jan 1999 To: 28 Jan 1999

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the animals
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 mL (54 mg)
The test substance was crushed to a fine powder for eye treatment.
Duration of treatment / exposure:
single application without washing
Observation period (in vivo):
72 h
Reading time points: 1, 24, 48 and 72 h
Number of animals or in vitro replicates:
6
Details on study design:
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 6 animals
Time point:
other: mean after 24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: mean after 24/48/72 h
Score:
0.11
Max. score:
2
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: mean after 24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: reversibility: not applicable
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: mean after 24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritant / corrosive response data:
Slight to moderate effects on the conjunctivae (redness and chemosis) and slight effects on the iris (congestion) were observed in all animals 1 h after test substance instillation. In a single animal, effects on the iris persisted up to 48 h and reversed thereafter. No effects on cornea were observed in any animal tested.
Other effects:
No further local or systemic effects were observed.

Any other information on results incl. tables

Table 1. Results of eye irritation study

Rabbit #

Time [h]

conjunctivae

 

iris

cornea

redness

chemosis

1

1

1

1

1 l

0 h

24

0

0

0

0

48

0

0

0

0

72

0

0

0

0

average

0

0

0

0

2

1

1

0

1 c

0

24

0

0

0

0

48

0

0

0

0

72

0

0

0

0

average

0

0

0

0

3

1

2

1

1 c

0

24

0

0

1 l

0

48

0

0

1 l

0

72

0

0

0

0

average

0

0

0.67

0

4

1

2

1

1 l

0

24

0

0

0

0

48

0

0

0

0

72

0

0

0

0

average

0

0

0

0

5

1

2

2

1 l

0

24

0

0

0

0

48

0

0

0

0

72

0

0

0

0

average

0

0

0

0

6

1

1

1

1 l

0

24

0

0

0

0

48

0

0

0

0

72

0

0

0

0

average

0

0

0

0

 

 

Time [h]

conjunctivae

 

iris

cornea

 

redness

swelling

 

 

average
score

1

1.50

1.00

1

0

24

0.00

0.00

0

0

48

0

0

0

0

72

0

0

0

0

24+48+72

0

0

0.11

0

h = slight adherence of the test article to the corneal surface; c = circumcorneal injections + congestions of the iris; l = circumcorneal injections

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