Registration Dossier
Registration Dossier
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EC number: 249-060-1 | CAS number: 28510-23-8
Endpoint summary
Administrative data
Description of key information
Skin irritation:
according to OECD 404, in compliance with GLP, RL2: not irritating
Eye irritation:
according to OECD 405, in compliance with GLP, RL2: not irritating
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 04 Mar - 10 Mar 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study with acceptable restrictions (analytical purity is not reported, occlusive dressing, residual test substance was not removed)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted in 1983
- Deviations:
- yes
- Remarks:
- Analytical purity is not reported, occlusive dressing, residual test substance was not removed.
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: Chbb: HM
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: Fa. Thomae, Biberach, Germany- Weight at study initiation: 2.5 kg- Housing: individual - Diet: Zucht- / Haltungsdiät - Water: tap water, ad libitum- Acclimation period: at least 7 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 20-21- Humidity (%): 45-50- Photoperiod (hrs dark / hrs light): 12 / 12
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated sites of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL- Amount(s) applied (volume or weight with unit): 0.5 mL
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 3 daysReading time points: 1, 24, 48 and 72 h
- Number of animals:
- 4 males
- Details on study design:
- TEST SITE- Area of exposure: back - Type of wrap if used: the treated skin was covered with a linen patch (2.5 cm x 2.5 cm). This was then covered with a large plastic foil, which was held in place with tape. Finally, by mean of a bond a secure fixation was achieved. SCORING SYSTEM: Draize scoring system
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- out of all 4 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- out of all 4 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- No skin irritations were observed.
- Other effects:
- No further effects were observed.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classifiedDSD: not classified
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Only abstract available
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Abstract, only results given
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- No data
- Type of coverage:
- not specified
- Preparation of test site:
- not specified
- Vehicle:
- not specified
- Controls:
- other: not required, untreated sites of the same animal served as control
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 hReading time points: 24, 48 and 72 h
- Number of animals:
- 3
- Details on study design:
- SCORING SYSTEM:Draize scoring system
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- out of 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- There were no signs of irritations observed in two animals. Slight erythema and transient slight oedema were observed in the third rabbit with complete regression 2 days after removal of the test substance.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classifiedDSD: not classified
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 29 May 1996 - 31 May 1996
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Only abstract avilable
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- : Only basic data on test substance and procedure given
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- not specified
- Preparation of test site:
- not specified
- Vehicle:
- not specified
- Controls:
- other: not required, untreated sites of the same animal served as control
- Amount / concentration applied:
- No data
- Duration of treatment / exposure:
- No data
- Observation period:
- 7 days Reading time points: 4, 24, 48 and 72 h and 7 days
- Number of animals:
- 3
- Details on study design:
- SCORING SYSTEM: Draize scoring system
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 28 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- ot all three animals
- Time point:
- other: mean out of 24 h, 48 h and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- No effects were seen in any animals at any reading time points.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classifiedDSD: not classified
Referenceopen allclose all
Reading scores:
| Time | Animal | Erythema | Edema |
| 24 h | 1 | 0 | 0 |
| 2 | 0 | 0 | |
| 3 | 1 | 0 | |
| 48 h | 1 | 0 | 0 |
| 2 | 0 | 0 | |
| 3 | 0 | 0 | |
| 72 h | 1 | 0 | 0 |
| 2 | 0 | 0 | |
| 3 | 0 | 0 | |
| mean 24 - 72 h | 1 | 0.0 | 0.0 |
| 2 | 0.0 | 0.0 | |
| 3 | 0.3 | 0.0 | |
| mean | 0.1 | 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 01 Jul - 08 Jul 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study with acceptable restrictions (analytical purity not reported)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted in 1984
- Deviations:
- yes
- Remarks:
- analytical purity not reported; single application without washing.
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: Chbb: HM
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS- Source: Thomae, Biberach, Germany- Weight at study initiation: 2.7 kg- Housing: individual housing- Diet: Altromin-Haltungsdiät, ad libitum- Water: tap water, ad libitum- Acclimation period: at least 7 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 20-21- Humidity (%): 45-55- 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 application without washing
- Observation period (in vivo):
- 3 daysReading time points: 1, 6, 24, 48, and 72 h
- Number of animals or in vitro replicates:
- 4 males
- Details on study design:
- SCORING SYSTEM: Draize scoring systemTOOL USED TO ASSESS SCORE: fluorescein
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- mean out of all 4 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- mean out of all 4 animals
- Time point:
- other: mean over 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- mean out of all 4 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- mean out of all 4 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- Slight conjuctival reactions were observed between 1-6 hours after treatment. They consisted in redness (4/4 animals within the first hour after treatment, 3/4 within 6 hours after treatment) and exudation (4/4 animals within the first hour after treatment). However, these reactions were fully reversible within 24 hours after treatment.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- CLP: not classifiedDSD: not classified
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Only abstract available
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- limited data
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- not specified
- Vehicle:
- not specified
- Controls:
- other: the untreated eye served as control
- Duration of treatment / exposure:
- single application
- Observation period (in vivo):
- 3 daysReading time points: 1 h and 1, 2 and 3 days
- Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- SCORING SYSTEM:Draize scoring system
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 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:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks:
- reversibility: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- Slight erythema were noted in all animals 1 h after instillation. While this reaction was absent in two animals at the following reading time points, it last in the third animal until the 2 day reading time point. Erythema was seen in one animal and discharge in all three animals. However this were only seen 1 h after instillation.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- CLP: not classifiedDSD: not classified
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 28 May 1996 - 30 May 1996
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Only abstract available
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- : Only basic data on test substance and procedure given.
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- No data
- Vehicle:
- not specified
- Controls:
- not required
- Amount / concentration applied:
- No data
- Duration of treatment / exposure:
- No data
- Observation period (in vivo):
- 7 daysReading time points: 4, 24, 48, 72 h and 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM: Draize scoring system
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- mean out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- mean out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- Conjunctival reactions were observed in all three animals after 4 hours. These reactions disappeared within 24 hours in one animal, while in the other two animals the effects were completely reversed after 48 hours.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classifedDSD: not classified
Referenceopen allclose all
Reading Scores:
| Reading time point | Animal No. | Cornea | Iris | Conjunctiva | |||
| Opacity | Area of opacity | Redness | Chemosis | Discharge | |||
| 1 h | 1100 | 0 | 0 | 0 | 1 | 0 | 3 |
| 1101 | 0 | 0 | 0 | 1 | 1 | 1 | |
| 1102 | 0 | 0 | 0 | 1 | 0 | 4 | |
| Day 1 | 1100 | 0 | 0 | 0 | 0 | 0 | 0 |
| 1101 | 0 | 0 | 0 | 1 | 0 | 0 | |
| 1102 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Day 2 | 1100 | 0 | 0 | 0 | 0 | 0 | 0 |
| 1101 | 0 | 0 | 0 | 1 | 0 | 0 | |
| 1102 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Day 3 | 1100 | 0 | 0 | 0 | 0 | 0 | 0 |
| 1101 | 0 | 0 | 0 | 0 | 0 | 0 | |
| 1102 | 0 | 0 | 0 | 0 | 0 | 0 | |
| mean days 1-3 | 1100 | 0.0 | 0.0 | 0.0 | 0 | ||
| 1101 | 0.0 | 0.0 | 0.7 | 0 | |||
| 1102 | 0.0 | 0.0 | 0.0 | 0 | |||
| mean | 0.0 | 0.0 | 0.2 | 0 | |||
Animal Number | 4 h | 1 day | 2 days | 3 days | 7 days | ||||||||||
CO | COR | IR | CO | COR | IR | CO | COR | IR | CO | COR | IR | CO | COR | IR | |
446 | 3 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
447 | 3 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
448 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
CO: Conjunctivae Score
COR: Cornea Score
IR: Iris 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 no sufficient data available for skin and eye irritation of 2,2-dimethylpropane-1,3-diyl 2-ethylhexanoate (CAS 28510-23-8). In order to fulfil the standard information requirements set out in Annex IX, 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, 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.
Skin and eye irritation/corrosion
CAS | 28510-23-8 | 97281-24-8 |
Chemical name | 2,2-dimethylpropane-1,3-diyl 2-ethylhexanoate | Fatty acids, C8-10, mixed esters with neopentylglycol and trimethylolpropane |
MW | 356.55 g/mol | 256.54-596.94 g/mol |
Skin irritation | RA: CAS 97281-24-8 | Experimental result: not irritating |
Eye irritation | RA: CAS 97281-24-8 | Experimental result: not irritating |
The above mentioned substances are considered to be similar on the basis of the structural similarity resulting in similar properties and/or activities. The available endpoint information is used to predict the same endpoints for 2,2-dimethylpropane-1,3-diyl 2-ethylhexanoate (CAS 28510-23-8).
A detailed analogue approach justification is provided in the technical dossier (see IUCLID Section 13).
Discussion
Skin irritation
Skin irritation was evaluated in a study performed with three New Zealand White rabbits in accordance with OECD guideline 404 (Bouffechoux, 1996a). The animals were treated with 2,2-dimethylpropane-1,3-diyl 2-ethylhexanoate.The readings of the treated skin sites after 4, 24, 48 and 72 h and 7 days revealed no noticeable irritation effects. As a consequence, the mean scores for erythema and edema were 0 in all animals, respectively. Thus, no skin irritating potential of the test substance was supposed. No final decision on classification was possible as important information as test material purity, amount of substance applied, coverage, and duration of treatment were not specified in detail.
Further supporting data on the skin irritation of 2,2-dimethylpropane-1,3-diyl 2-ethylhexanoateare available (Duerden, 1994a). In another rabbit study performed according to GLP and similar to OECD guideline 404 with2,2-dimethylpropane-1,3-diyl 2-ethylhexanoate no irritating effects were observed. The mean scores for erythema were 0.33 in one animal and 0 in the two other animals, while the edema scores were 0 for all animals, respectively. No final decision on classification was possible as only limited data on test material purity, amount of substance applied, and coverage, were available.
As the two studies that were performed with the test substance did not allow a final decision on classification due to limited data, an appropriate read-across was performed from the analogue substanceFatty acids, C8-10, mixed esters with neopentylglycol and trimethylolpropane (CAS 97281-24-8). Fatty acids, C8-10, mixed esters with neopentylglycoland trimethylolpropanewas tested for skin irritation in a study with rabbits in compliance with GLP and similar to OECD guideline 404 (Kästner, 1988a). 0.5 mL of the test substance was applied to the skin of four male Chbb: HM rabbits for 4 h being kept under an occlusive dressing. 1, 24, 48 and 72 h after the patch removal the treated skin sites were evaluated for erythema and edema. The mean cores were 0, both for erythema and edema, in all animals. In conclusion, Fatty acids, C8-10, mixed esters with neopentylglycol and trimethylolpropane was not irritating to the skin.
Based on the fact that neither in the two studies with 2,2-dimethylpropane-1,3-diyl 2-ethylhexanoate nor in the study with the analogue substance Fatty acids, C8-10, mixed esters with neopentylglycol and trimethylolpropane skin irritation was observed, 2,2-dimethylpropane-1,3-diyl 2-ethylhexanoate is not to be classified for skin irritation.
Eye irritation
An eye irritation study was performed with2,2-dimethylpropane-1,3-diyl 2-ethylhexanoateaccording to OECD 405 (Bouffechoux, 1996b). After treatment with the test substance, no effects on cornea and iris were observed. Conjunctiva mean scores (over 24, 48, and 72 h) of 0.0, 0.3, and 0.3 were observed in animal 1, 2, and 3, respectively. The effects on conjunctiva were fully reversible within 48 h.No final decision on classification was possible as important information as test material purity, amount of substance applied, and duration of treatment were not specified in detail.
A further eye irritation study was performed with2,2-dimethylpropane-1,3-diyl 2-ethylhexanoateequivalent or similar to OECD 405 (Duerden, 1994b). After treatment with the test substance, no effects on cornea and iris and no chemosis were observed. Conjunctivae mean scores (over 24, 48, and 72 h) of 0, 0, and 0.67 were observed in animal 1, 2, and 3, respectively. The effects on conjunctiva were fully reversible within 72 h. Againno final decision on classification was possible as important information as test material purity and amount of substance applied were not specified in detail.
As the two studies that were performed with the test substance did not allow a final decision on classification due to limited data, an appropriate read-across was performed from the analogue substanceFatty acids, C8-10, mixed esters with neopentylglycol and trimethylolpropane (CAS 97281-24-8).Theeye irritation potential of the structural analogueFatty acids, C8-10, mixed esters with neopentylglycol and trimethylolpropanewas evaluated in a GLP study performed equivalent or similar to OECD guideline 405 (Kästner, 1988b). 0.1 mL ofFatty acids, C8-10, mixed esters with neopentylglycol and trimethylolpropanewas instilled into the eyes of fourChbb: HM rabbits. The eyes were observed 1, 6, 24, 48, and 72 h after application. Slight conjunctival reactions (grade 1) were observed up to 6 h after treatment in 4/4 animals. These were fully reversible within 24 h. No effects on cornea and iris and no chemosis were observed throughout the study period.
Based on the fact that neither in the two studies with 2,2-dimethylpropane-1,3-diyl 2-ethylhexanoate nor in the study with the analogue substance Fatty acids, C8-10, mixed esters with neopentylglycol and trimethylolpropane eye irritation was observed, 2,2-dimethylpropane-1,3-diyl 2-ethylhexanoate is not to be classified for skin irritation.
Conclusion
In conclusion, the available data on the skin and eye irritation potential of 2,2-dimethylpropane-1,3-diyl 2-ethylhexanoate and a structural analogue substance indicate that 2,2-dimethylpropane-1,3-diyl 2-ethylhexanoate is not irritating to the skin and eye.
Justification for selection of skin irritation / corrosion 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 (refer to the endpoint discussion for further details).
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 (refer to the endpoint discussion for further details).
Justification for classification or non-classification
The available data on skin and eye irritation of the test substance do not meet the criteria for classification according to Regulation (EC 1272/2008 or Directive 67/548/EEC, 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.
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