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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 253-675-0 | CAS number: 37811-72-6
- 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 irritation (OECD 404), rabbit: not irritating (RA CAS 10233-13-3 and RA CAS 123-95-5)
Eye irritation (OECD 405), rabbit: not irritating (RA CAS 110-27-0)
Key value for chemical safety assessment
Skin irritation / corrosion
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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions (limited documentation on test substance purity and test protocol).
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- limited documentation on test substance purity and test protocol
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 1800 - 2400 g - 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 instillation without washout
- Observation period (in vivo):
- 7 days in the absence of any irritation reaction
Reading time points: 24h, 48h, 72h, 4 days and 7 days - Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE: No
SCORING SYSTEM: according to Draize scale for scoring ocular lesions
TOOL USED TO ASSESS SCORE: hand-held lenses - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- After instillation of the test substance into rabbit eyes there was slight conjunctival irritation observed, that was reversible after 48h.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
Reference
Table 1: Individual irritation scores
Animal Number |
Hours after Application |
|||||||||||
24 |
48 |
72 |
||||||||||
A |
B |
C |
D |
A |
B |
C |
D |
A |
B |
C |
D |
|
1 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
A = Cornea Score
B = Iris Score
C = Conjunctiva Score
D = Chemosis Score
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for grouping of substances and read-across
There are only limited data available on skin and eye irritation of isobutyl laurate (CAS 37811-72-6). In order to fulfil the standard information requirements set out in Annex VII and VIII, 8.1. and 8.2., in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from structurally related substances was conducted. In accordance with Article 13 (1) of Regulation (EC) No 1907/2006, "information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met.” In particular for human toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, which includes the use of information from structurally related substances (grouping or read-across). Having regard to the general rules for grouping of substances and read-across approach laid down in Annex XI, Item 1.5, of Regulation (EC) No 1907/2006 whereby substances may be predicted as similar provided that their physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity.
Overview of skin and eye irritation
CAS |
Chemical name |
Molecular weight [g/mol] |
Skin irritation |
Eye irritation |
37811-72-6 (a) |
Isobutyl laurate |
256.42 |
WoE: RA: CAS 10233-13-3 RA: CAS 123-95-5 |
RA: CAS 110-27-0 |
110-27-0 (b) |
Isopropyl myristate |
270.45 |
Experimental result: not irritating |
Experimental result: not irritating |
10233-13-3 (b) |
Isopropyl laurate |
242.40 |
Experimental result: not irritating |
-- |
123-95-5 (b) |
Butyl stearate |
340.59 |
Experimental result: not irritating |
Experimental result: not irritating |
(a) The substance subject to registration is indicated in bold font.
(b) Reference (read-across) substances are indicated in normal font. Lack of data for a given endpoint is indicated by “--“.
The above mentioned substances are considered to be similar on the basis of the structural similar properties and/or activities. The available endpoint information is used to predict the same endpoints for isobutyl laurate (CAS 37811-72-6). A detailed analogue approach justification is provided in the technical dossier (see IUCLID Section 13).
Discussion
No data on skin and eye irritation is available with isobutyl laurate (CAS 37811-72-6). Therefore, read across from the structurally analogue substances isopropyl myristate (CAS 110-27-0), isopropyl laurate (CAS 10233-13-3) and butyl stearate (CAS 123-95-5) was applied.
Skin irritation
CAS 10233-13-3
In the reliable skin irritation study performed according to OECD TG 404 three male New Zealand rabbits were exposed to 0.5 mL of the neat test material (CAS 10233-13-3) for 4 hours applied onto the shaved skin via occlusive dressing (Dufour, 1991). Skin reactions were evaluated according to the Draize scoring system 1, 24, 48 and 72 hours and 7 days post-application. No symptoms of systemic toxicity were observed in any animal during the test period and no mortality occurred during the course of the study. Very slight erythema and edema formation (grade 1) were observed for 1/3 animals 24 and 24 hours post-application which were fully reversible within 72 hours. The mean value for erythema and edema were calculated to be 0.67.
CAS 123-95-5
In the reliable skin irritation study performed according to OECD TG 404 three Albino rabbits of each sex were exposed to 0.5 mL of the neat test material (CAS 123-95-5) for 24 hours applied onto the shaved intact and abraded skin via occlusive dressing (Wallace, 1976). Skin reactions were evaluated according to the Draize scoring system 24 and 72 hours post-application. No symptoms of systemic toxicity were observed in any animal during the test period and no mortality occurred during the course of the study. Very slight erythema (grade 1) were observed in 2/6 (intact skin) and 3/6 (abraded skin) animals 24 hours post application which were fully reversible within 72 hours. The mean values for erythema were calculated to be 0.22 (intact skin) and 0.33 (abraded skin), respectively. No edema formation (neither intact nor abraded skin) was observed in any animal during the entire study period.
Taken together, the available data on skin irritation from structural analogue substances do not indicate any irritating potential. Therefore, according to EU classification criteria, the target substance isobutyl laurate (CAS 37811-72-6) is not to be classified.
Eye irritation
CAS 110-27-0
In the reliable eye irritation study with isopropyl myristate (CAS 110-27-0) performed equivalent or similar to OECD TG 405 (Palanker, 1977) 0.1 mL of the neat test material was instilled in the eye of three New Zealand White rabbits. The eyes were examined and the changes were graded according to the Draize scoring system 24, 48 and 72 hours and 4 and 7 days post-application. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred during the course of the study. Neither iridial irritation nor corneal opacity and chemosis were observed in any animal during the course of the study. 2/3 animals showed slight conjunctivae irritation (grade 0.33) which was fully reversible within 48 hours.
Therefore, according to EU classification criteria, the target substance isobutyl laurate (CAS 37811-72-6) is not to be classified.
Justification for selection of skin irritation / corrosion
endpoint:
Hazard assessment is conducted by means of read-across from
structural analogues. All available studies are adequate and reliable
based on the identified similarities in structure and intrinsic
properties between source and target substances and overall quality
assessment.
Justification for selection of eye irritation endpoint:
Hazard assessment is conducted by means of read-across from a
structural analogue. The selected study is the most adequate and
reliable study based on the identified similarities in structure and
intrinsic properties between source and target substance and overall
quality assessment.
References:
A detailed reference list is provided in the technical dossier (see IUCLID, section 13) and within the CSR.
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 isobutyl laurate (CAS 37811-72-6), 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.