Registration Dossier
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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 237-725-9 | CAS number: 13945-76-1
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Skin, rabbit (equivalent to OECD 404, read across): not irritating
Eye, in vitro (OECD 492, read across): not irritating
Eye, rabbit (OECD 405, read across): not irritating
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11 - 18 Mar 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- The exposure was performed under occlusive conditions, the analytical purity of the test substance was not specified.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted in 1981
- Deviations:
- yes
- Remarks:
- occlusive exposure
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated skin site of the same animal served as the control
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
Reading time points: 1, 24, 48 and 72 h - Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Type of wrap if used: occlusive
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated site was not washed after patch removal
SCORING SYSTEM: Draize scoring system - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- mean over
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- mean over
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- mean over
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- mean over
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- mean over
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- mean over
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibilty not applicable
- Irritant / corrosive response data:
- 1 hour after exposure, all the animals had slight to well-defined erythema, while 2/3 had very slight to slight edema. These effects gradually reduced in severity. 24 hours after exposure ended, 1/3 animals had very slight erythema and slight edema. the edema persisted until the 48-hour reading time point.All skin irritation effects had cleared completely within 72 hours after the exposure ended.
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 18 Dec - 23 Dec 1995
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- only basic data given, test substance purity not specified
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- other: New Zealand
- Type of coverage:
- not specified
- Preparation of test site:
- not specified
- Vehicle:
- not specified
- Controls:
- not required
- Duration of treatment / exposure:
- single application
- Observation period:
- Reading time points: 1, 24, 48 and 72 h
7 days - Number of animals:
- 3
- Details on study design:
- SCORING SYSTEM: Draize scoring system
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- mean over
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- mean over
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- mean over
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2, #3
- Remarks:
- mean over
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritant / corrosive response data:
- Desquamative reaction, with moderated cutaneous extensive range index for 3 animals from Day 4 to Day 7 was observed.
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Basic data given. The test substance was applied under occlusive conditions for 24 hours, no experimental 48 h reading was performed, few data were reported.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- exposure period 24 h, occlusive conditions, no experimental 48 h reading performed, few details reported
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved and abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: not required, the untreated site of the same animal served as the control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- 24 h
- Observation period:
- 72 h
Reading time points: 24 and 72 h - Number of animals:
- 6 males
- Details on study design:
- SCORING SYSTEM: Draize scoring system
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- mean over
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Remarks on result:
- other: no 48 h data are available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h)
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- mean over
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: no 48 h data are available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h)
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- mean over
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Remarks on result:
- other: no 48 h data are available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h)
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Remarks:
- mean over
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Remarks on result:
- other: no 48 h data are available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h)
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Remarks:
- mean over
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Remarks on result:
- other: no 48 h data are available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h)
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Remarks:
- mean over
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Remarks on result:
- other: no 48 h data are available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h)
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2, #3, #4, #5, #6
- Remarks:
- mean over
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Remarks on result:
- other: no 48 h data are available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h)
- Irritant / corrosive response data:
- Intact skin:
1/6 animals had slight erythema (score 1 of 4) at the 24-hour reading time point, which had cleared completely by the 72-hour reading time point (see Table 1). No other skin irritation effects were observed in any animals.
Abraded skin:
1/6 animals had slight erythema (score 1 of 4) at the 24-hour reading time point. The skin irritation had cleared within 48 hours. - Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
Referenceopen allclose all
Table 1: Erythema and edema scores for skin irritation of the individual animals at different reading time points:
Observation time |
Rabbit no. |
|||||
1 |
2 |
3 |
||||
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
|
1 h |
2 |
2 |
1 |
0 |
1 |
1 |
24 h |
1 |
2 |
0 |
0 |
0 |
0 |
48 h |
0 |
1 |
0 |
0 |
0 |
0 |
72 h |
0 |
0 |
0 |
0 |
0 |
0 |
Mean value 24 + 48 + 72 h |
0.33 |
1.00 |
0 |
0 |
0 |
0 |
Mean value 24 + 48 + 72 h all animals |
0.11 |
0.33 |
|
|
|
|
Table 1: Results of skin irritation study
Observation time |
Animal no. |
|||||
1 |
2 |
3 |
||||
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
|
1 h |
0 |
0 |
0 |
0 |
1 |
0 |
24 h |
2 |
0 |
2 |
0 |
2 |
0 |
48 h |
1 |
0 |
2 |
0 |
2 |
0 |
72 h |
0 |
0 |
0 |
0 |
2 |
0 |
7 d |
0 |
0 |
0 |
0 |
0 |
0 |
Mean value 24 + 48 + 72 h |
1.0 |
0 |
1.33 |
0 |
2.0 |
0 |
Table 1: individual erythema and edema scores for intact skin
Observation time |
Rabbit No. |
|||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
|||||||
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
|
24 h |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
48 h |
No experimental data available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption)
|
|||||||||||
72 h |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Table 2: calculation of mean scores for intact skin
|
Rabbit No. |
|||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
|||||||
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
|
Mean value 24+48+72 h |
0 |
0 |
0.67 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 19 Dec - 21 Dec 1995
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted in 1987
- Deviations:
- yes
- Remarks:
- : only basic data given, lack of details on test substance, no chemosis scores determined
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted in 2017
- Deviations:
- yes
- Remarks:
- No rationale for in vivo testing, limited documentation
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- other: New Zealand
- Vehicle:
- not specified
- Controls:
- not specified
- Duration of treatment / exposure:
- No data
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM: Draize scoring system
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, #3
- Remarks:
- mean over
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, #3
- Remarks:
- mean over
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1, #2, #3
- Remarks:
- mean over
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 15 May - 16 Jul 1987
- 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:
- adopted in 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted in 2017
- Deviations:
- yes
- Remarks:
- no rationale for in vivo testing; limited documentation details
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: The Broekman Institute, Someren, The Netherlands
- Age at study initiation: 8 - 9 weeks
- Weight at study initiation: 2693 - 2894 g
- Housing: individually in plastic cages with perforated floors
- Diet: standard animal diet (100 g per day), obtained from Hope Farms, Woerden (LK-01, pellet diameter 4 mm)
- Water: tap-water, ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 21
- Humidity (%): 60 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- Single eye instillation
- Observation period (in vivo):
- 72 hours (in the absence of any persistent sign of irritation)
Reading time points: 1, 24, 48 and 72 hours after instillation - Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, #3
- Remarks:
- mean over
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, #3
- Remarks:
- mean over
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1, #2, #3
- Remarks:
- mean over
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #2, #3
- Remarks:
- mean over
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- 2 out of 3 animals showed only slight swelling of the blood-vessels in the conjunctivae 1 hour after instillation. The effects were fully reversible 24 hours after instillation. The fluorescein analysis 24 hours after instillation did not reveal any epithelial damage.
- Other effects:
- Signs of systemic intoxication were not observed.
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Referenceopen allclose all
Table 1: Results of eye irritation test
Rabbit No. / sex |
Scoring [h] |
Cornea |
Iris |
Conjunctiva |
1 / m |
1 |
0 |
0 |
1 |
|
24 |
0 |
0 |
1 |
|
48 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
|
7 days |
0 |
0 |
0 |
Mean (24, 48, 72 h) |
0 |
0 |
0.33 |
|
2 / m |
1 |
0 |
0 |
2 |
|
24 |
0 |
0 |
1 |
|
48 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
|
7 days |
0 |
0 |
0 |
Mean (24, 48, 72 h) |
0 |
0 |
0.33 |
|
3 / m |
1 |
0 |
0 |
2 |
|
24 |
0 |
0 |
1 |
|
48 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
|
7 days |
0 |
0 |
0 |
Mean (24, 48, 72 h) |
0 |
0 |
0.33 |
Table 1: Results of eye irritation test
Rabbit No. / sex |
Scoring [h] |
Cornea |
Iris |
Conjunctiva |
|
Redness |
Chemosis |
||||
1 / f |
1 |
0 |
0 |
1 |
0 |
|
24 |
0 |
0 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
Mean (24, 48, 72 h) |
0 |
0 |
0 |
0 |
|
2 / f |
1 |
0 |
0 |
0 |
0 |
|
24 |
0 |
0 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
Mean (24, 48, 72 h) |
0 |
0 |
0 |
0 |
|
3 / f |
1 |
0 |
0 |
1 |
0 |
|
24 |
0 |
0 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
Mean (24, 48, 72 h) |
0 |
0 |
0 |
0 |
|
Group mean |
0 |
0 |
0 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Read across justification
There are no available data on the skin and eye irritation effects of Lauryl laurate (CAS 13945-76-1). The assessment was therefore based on studies conducted with analogue substances as part of a read across approach, which is in accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.5. For each specific endpoint the source substance(s) structurally closest to the target substance is/are chosen for read-across, with due regard to the requirements of adequacy and reliability of the available data. Structural similarities and similarities in properties and/or activities of the source and target substance are the basis of read-across. A detailed justification for the analogue read-across approach is provided in the technical dossier (see IUCLID Section 13).
Skin irritation
CAS 95912-86-0
A skin irritation study similar to OECD guideline 404 (key study, 1991) was performed with Fatty acids, C8-10, C12-18-alkyl esters (CAS 95912-86-0). 0.5 mL of the undiluted test substance was applied to the shaved skin of 3 male rabbits for 4 hours under occlusive conditions. The local skin effects were scored 1, 24, 48, and 72 h after exposure ended. At the 24-hour reading time point 1/3 rabbits showed erythema (score 1), which was fully reversible within 48 hours. Oedema was seen in 1/3 rabbits with score 2 at the 24-hour reading and score 1 at the 48 hour reading, which was fully reversible within 72 hours.
The mean erythema scores (over 24, 48 and 72 hours) were 0.33, 0.0 and 0.0 while the mean oedema scores (over 24, 48 and 72 hours) were 1.0, 0.0 and 0.0. Based on these results, the test substance is not considered to be irritating to the skin.
CAS 20292-08-4
A skin irritation study similar to OECD guideline 404 (supporting study, 1996) was performed with 2-ethylhexyl laurate (CAS 20292-08-4). An unknown amount of the test substance was single applied to the skin of 3 male rabbits for an unknown exposure duration. The local skin effects were scored 1, 24, 48 and 72 h, and 7 days after exposure ended. At the 24-hour reading time point 3/3 rabbits showed well-defined erythema (score 2), which persisted as slight to well-defined erythema (score 1-2) for 48 hours in 3/3 animals and was still present in 1/3 animals at the 72-hour reading time point. No oedema was observed at any time point in any animal. All local skin irritation had cleared completely within 7 days after the exposure ended. The mean erythema scores (over 24, 48 and 72 hours) were 1.0, 1.33 and 2.0 while the mean oedema scores (over 24, 48 and 72 hours) were 0.0, 0.0 and 0.0. Based on these results, the test substance is not considered to be irritating to the skin.
CAS 3234-85-3
A skin irritation study similar to OECD guideline 404 (supporting study, 1985) was performed with Tetradecanoic acid, tetradecyl ester (CAS 3234-85-3). 0.5 g of the test substance was applied to the shaved and abraded skin of 6 male rabbits for 24 hours of exposure under occlusive conditions. The local skin effects were scored at 24 and 72 h. At the 24-hour reading time point 1/6 rabbits showed erythema (score 1), which was fully reversible at 72-hour reading. No oedema was observed at any time point in any animal. Scores for the omitted 48h reading were assumed to be the same as at 24h reading (worst case assumption).The mean erythema scores (over 24, 48 and 72 hours) were 0.67, 0.0, and 0.0 while the mean oedema scores (over 24, 48 and 72 hours) were 0, 0 and 0. Based on these results, the test substance is not considered to be irritating to the skin.
Eye irritation
CAS 17671-26-0
The eye irritation properties of Lauryl nonanoate were tested in an in vitro study according to OECD 492 and in compliance with GLP (key study, 2018). The EpiOcular™ cornea epithelial model was exposed to 50 μL of the neat/ undiluted test substance for 30 minutes and was incubated for another 2 hours after rinsing and removal of the test substance and 12 minutes of post-soak immersion. After treatment with the negative control the absorbance values were well within the required acceptability criterion of OD > 0.8 and < 2.5 thus showing the quality of the tissues. Treatment with the positive control induced a decrease below 50% compared with the negative control value in the relative absorbance thus ensuring the validity of the test system. The viability test (MTT) with the test substance revealed a mean tissue viability of 95% compared with the value of the negative control. Based on the obtained results, Lauryl nonanoate (CAS 17671-26-0) is not eye irritating.
CAS 92044-87-6
An eye irritation study was performed with Fatty acids, coco, 2-ethylhexyl ester (CAS 92044-87-6) according to OECD guideline 405 (WoE, 1987). 0.1 mL of the test substance was instilled into the eyes of 3 female New Zealand White rabbits. The animals were observed for 72 hours and scoring according to Draize was performed 1, 24, 48, and 72 hours after application. The eyes were not rinsed. At the 1-hour reading time point 2/3 rabbits had slight conjunctivae (score 1). The effects had cleared completely by the 24-hour reading time point. No effects on the cornea and iris were noted, and no chemosis was reported at any time point in any animal. The mean cornea score and iris score (over 24, 48 and 72 hours) was 0 for all animals, respectively. The mean conjunctivae score and chemosis score (over 24, 48 and 72 hours) was 0 for all animals, respectively. Based on the results of the study, the test substance is not considered to be irritating to the eyes.
CAS 20292-08-4
2-hexyl laurate (CAS 20292-08-4) was examined for its eye irritation potential in a study performed following a protocol similar to OECD guideline 405 (supporting study, 1996). An unknown amount of undiluted test substance was instilled into one eye of each of 3 rabbits. The animals were observed for 7 days and scoring according to Draize was performed 1, 24, 48, and 72 hours after application. At the 1-hour reading time point slight to well-defined conjunctivae (score 1-2) was noted in 3/3 animals, which persisted as slight conjunctivae (score 1) until 24 h after installation. The eye irritation effects had cleared completely within 48 h. All the scores for both rabbits were 0 for corneal and iris effects. No scoring was performed for chemosis. Under the conditions of the study, the test substance showed no eye irritating potential.
Overall conclusion for skin and eye irritation
The available data on suitable source substances did not show any skin or eye irritation effects. Therefore, the target substance Lauryl laurate (CAS 13945-76-1) is not expected to be a skin irritant or an eye irritant.
Justification for classification or non-classification
According to Article 13 of Regulation (EC) No. 1907/2006 "General Requirements for Generation of Information on Intrinsic Properties of substances", information on intrinsic properties of substances may be generated by means other than tests e.g. from information from structurally related substances (grouping or read-across), provided that conditions set out in Annex XI are met. Annex XI, "General rules for adaptation of this standard testing regime set out in Annexes VII to X” states that “substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or ‘category’ of substances. This avoids the need to test every substance for every endpoint". Since the analogue concept is applied to Lauryl laurate (CAS 13945-76-1), data will be generated from data for reference source substance(s) to avoid unnecessary animal testing. Additionally, once the analogue read-across concept is applied, substances will be classified and labelled on this basis.
Therefore, based on the analogue read-across approach, the available data on skin and eye irritation do not meet the classification criteria according to Regulation (EC) 1272/2008 and are therefore conclusive but not sufficient for classification.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.