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Diss Factsheets

Administrative data

Description of key information

The test item 2,2-Dimethyl-3-lauroyloxy-propanal applied to the rabbits’ skin evoked no observable irritating response. Thus, the classification of the test item as a skin irritant is not required.
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.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2004-11-03 to 2004-11-06
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
24 April 2002
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
Directive 92/69/EEC
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source:Ferenc Sándor breeder, 2173 Kartal, Vörös Hadsereg Street 131, HUNGARY
- Age at study initiation: young adult rabbits 10 weeks old
- Weight at study initiation: 2513 - 2764 g
- Housing: Animals were housed individually in metal cages.
- Acclimation period: 7 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.
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 mL
- Concentration (if solution): 100 %
Duration of treatment / exposure:
4 hours
Observation period:
Animals were examined for signs of erythema and oedema, and the responses scored at 60 minutes, and then at 24, 48, 72 hours after the patch removal.
Number of animals:
3 male animals
Details on study design:
TEST SITE
- Area of exposure: 6 %.
- Type of wrap if used: plastic.

REMOVAL OF TEST SUBSTANCE
- Washing: Remaining test item was removed with water at body temperature.
- Time after start of exposure: 4 hours.

SCORING SYSTEM:
- The irritation effect of the test item was evaluated according to the Draize method (OECD No.: 404, 2002).
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
No response observed.
Other effects:
None.
Interpretation of results:
GHS criteria not met
Conclusions:
The test item 2,2-Dimethyl-3-lauroyloxy-propanal applied to the rabbits’ skin evoked no observable irritating response. Thus, the classification of the test item as a skin irritant is not required.
Executive summary:

The acute skin irritation study of 2,2-Dimethyl-3-lauroyloxy-propanal was performed in New Zealand White rabbits. The irritation effect of the test item was evaluated according to the Draize method (OECD No.: 404, 2002). The test item was administered in a pure state, as a single dose of 0.5 mL, to the shaved skin of all experimental rabbits. The untreated skin of each animal served as control. After 4 hours any remaining test item was removed with water at body temperature. The animals were examined at 1, 24, 48 and 72 hours after the patch removal. No irritation symptoms (erythema and oedema) or other signs occurred after the patch removal and during the 72-hour observation period, so the study was terminated at the 72nd hour. During the study the behaviour and general state of animals were normal. The animal’s individual mean scores (considering readings at 24, 48 and 72 hours after patch removal) for erythema and oedema were 0.00, 0.00, 0.00 and 0.00, 0.00, 0.00 respectively. Thus, the classification of the test item 2,2-Dimethyl-3-lauroyloxy-propanal as a skin irritant is not required.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2004-11-04 to 2004-10-07
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
24 April 2002
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
Directive 92/69/EEC
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
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.
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)
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
all animals
Time point:
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:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
all animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
all animals
Time point:
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.
Interpretation of results:
GHS criteria not met
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation


The acute skin irritation study of 2,2-Dimethyl-3-lauroyloxy-propanal was performed in New Zealand White rabbits. The irritation effect of the test item was evaluated according to the Draize method (OECD No.: 404, 2002). The test item was administered in a pure state, as a single dose of 0.5 mL, to the shaved skin of all experimental rabbits. The untreated skin of each animal served as control. After 4 hours any remaining test item was removed with water at body temperature. The animals were examined at 1, 24, 48 and 72 hours after the patch removal. No irritation symptoms (erythema and oedema) or other signs occurred after the patch removal and during the 72-hour observation period, so the study was terminated at the 72nd hour. During the study the behaviour and general state of animals were normal. The animal’s individual mean scores (considering readings at 24, 48 and 72 hours after patch removal) for erythema and oedema were 0.00, 0.00, 0.00 and 0.00, 0.00, 0.00 respectively. Thus, the classification of the test item 2,2-Dimethyl-3-lauroyloxy-propanal as a skin irritant is not required.


 


Eye irritation


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.

Justification for classification or non-classification

Based on the results obtained from testing of skin and eye irritation, no classification and labelling is required according to Regulation (EC) No 1272/2008 (CLP), as amended for the fifteenth time in Regulation (EU) No 2020/1182.