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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 from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
2004-11-04 to 2004-10-07
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Read across to hydrolysis product.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
24 April 2002
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
Directive 92/69/EEC
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Ferenc Sándor breeder, 2173 Kartal, Vörös Hadsereg Street 131, HUNGARY
- Age at study initiation: 10 weeks
- Weight at study initiation: 2594-2823 g
- Housing: Animals were housed individually in metal cages.
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C):20 +- 3 °C
- Humidity (%): 30-70 %
- Air changes (per hr): 8-12
- Photoperiod (hrs dark / hrs light): 12 hours daily, from 6.00 a.m. to 6.00 p.m.

Test system

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

Duration of treatment / exposure:
72 hours
Observation period (in vivo):
The eyes were examined at 1, 24, 48, and 72 hours after the application.
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM:
The eye irritation scores will be evaluated according to the scoring system by Draize (1959) and OECD 405 (24 April 2002)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
animal 1
Time point:
other: 24, 48, 72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal 1
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal 1
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal 1
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
animal 2
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal 2
Time point:
other: 24,48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal 2
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal 2
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
animal 3
Time point:
other: 24, 48, 72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal 3
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal 3
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal 3
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
all animals
Time point:
other: 24, 48, 72 h
Score:
0.22
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
all animals
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
all animals
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
all animals
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Irritant / corrosive response data:
One hour after treatment some hyperaemic blood vessels occurred in every animal. In two animals (animal No.: 16782, 17060) the discharge with moistening of the lids and hairs just adjacent to lids was found. In one case (animal No.: 16712) the discharge moistened the lids and considerable area around the treated eye. Chemosis, corneal and iris alterations were not found during the study. 24 hours after treatment in two animals (animal No.: 16712, 17060) some hyperaemic blood vessels occurred. In animal No.: 16712 the discharge from the eye was “any amount different from normal”. The animal No.: 16782 became fully symptom-free by this time. 48 and 72 hours after treatment every animal was symptom-free.
Other effects:
None.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item 2,2-Dimethyl-3-lauroyloxy-propanal, applied to the rabbits' eye mucosa, caused irritant effects, which can be evaluated as fully reversible alterations within 48h. According to the EU (DSD and GHS) criteria for classification and labelling requirements for dangerous substances and preparations the test item does not have to be classified and has no obligatory labelling requirement for eye irritation.
Executive summary:

The acute eye irritation study of the test item 2,2-Dimethyl-3-lauroyloxy-propanal was performed in three New Zealand White rabbits. The irritation effect of the test item was evaluated according to the Draize method (OECD No.: 405, 2002). The test item was placed into the conjunctival sac of the left eye of each animal. The untreated right eye served as control. The treated eyes of the test animals were not washed out following the instillation of 0.1 mL of the test item, which was administered in pure state, in a single dose. The eyes were examined at 1, 24, 48, and 72 hours after the application. One hour after the single application of 2,2-Dimethyl-3-lauroyloxy-propanal into the eyes of the rabbits slight redness and moderately or severely increased discharge were observed in the eyes of the test animals. Chemosis, corneal and iris alterations were not found during the study. 24 hours after treatment in two animals slight redness was observed and in one case slightly increased discharge was noted. One animal became fully symptom-free by this time. 48 hours after the treatment every animal was symptom-free. 72 hours after the treatment the study was terminated, since no primary irritation symptoms occurred. The general state and the behaviour of animals were normal during the whole study. In conclusion, the test item 2,2-Dimethyl-3-lauroyloxy-propanal, applied to the rabbits' eye mucosa, caused irritant effects, which can be evaluated as fully reversible alterations within 48 h. According to the EU (DSD and GHS) criteria for classification and labelling requirements for dangerous substances and preparations the test item does not have to be classified and has no obligatory labelling requirement for eye irritation.