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EC number: 295-371-0 | CAS number: 92044-91-2
- Life Cycle description
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- Endpoint summary
- Appearance / physical state / colour
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- Endpoint summary
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- 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
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- Endocrine disrupter testing in aquatic vertebrates – in vivo
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- 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): not irritating
RA from source substance (CAS 130905-60-1)
Skin irritation (similar to OECD 404 and Human Patch Test): not irritating
RA from source substance (CAS 63705-03-3)
Eye irritation (OECD 405): not irritating
RA from source substance (CAS 130905-60-1)
Eye irritation (similar to OECD 405): not irritating
RA from source substance (CAS 63705-03-3)
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:
- weight of evidence
- Study period:
- 16 - 20 August 1990
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted in 1981
- Deviations:
- yes
- Remarks:
- analytical purity not reported
- GLP compliance:
- yes
- Remarks:
- Bezirksregierung, Lüneburg, Germany
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harald Schriever, Kaninchenfarm, Bremervörde, Germany
- Weight at study initiation: 2.4 – 2.8 kg
- Housing: individual housing in a battery of cages, each equipped with a paper roll disposal system
- Diet: Ssniff MÜ ZR (Alleindiät für Zuchtkaninchen), pellets, ad libitum
- Water: drinking water as for human consumption, ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 2 °C
- Humidity (%): 50 -85%
- Photoperiod (hrs dark / hrs light): 12 / 12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- 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 days
Reading time points. 30- 60 min, 24, 48 and 72 h - Number of animals:
- 3 (sex not reported)
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm² on the back of each animal
- Type of wrap if used: The treated skin was covered with a semiocclusive dressing consisting of Kosmoplast R (Medilog), held in place by non-irritating tape Elastoplast R and Stülpa.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test material was removed with water or an appropriate solvent
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize scoring system - Irritation parameter:
- erythema 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:
- edema 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
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
- Conclusions:
- CLP: not classified
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Lack of data on test material. Occlusive conditions.
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: Kleinrusse, Chbb:HM
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Thomae, Biberach, Germany
- Age at study initiation: adult
- Weight at study initiation: 2.3 kg
- Housing: The animals were single housed in rabbit cages.
- Diet: 20 ZH 5, Nohrlin GmbH
- Water: tap water, ad libitum
- Acclimation period: at least 7 d
ENVIRONMENTAL 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: Not required, 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:
- 7 d
Reading time points: 1, 24, 48 and 72 h and 7 d - Number of animals:
- 4 males
- Details on study design:
- TEST SITE
- Area of exposure: 6.25 cm² on the dorsal area of the trunk
- Type of wrap if used: The treated skin was covered with a plastic film, held in place with adhesive plasters and acrylastic tape.
SCORING SYSTEM: Draize scoring system - Irritation parameter:
- erythema score
- Basis:
- other: mean out of all 4 animals
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- other: mean out of all 4 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- The dermal application of the test substance did not result in edema in any of the animals tested at any observation time point. Very slight to slight erythema formation was observed in 3/4 animals at the 24 and 48 h reading time points. At the 72 h reading time point, slight and moderate erythema formation was observed in 2/4 animals. The effects were reversible in all animals within 7 d after the application of the test substance.
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
- Conclusions:
- CLP: not classified
Referenceopen allclose all
Table 1. Results of skin irritation study
Observation time |
Rabbit no. |
||||||||
1 |
2 |
3 |
4 |
||||||
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
||
1 h |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
|
24 h |
0 |
0 |
1 |
0 |
1 |
0 |
2 |
0 |
|
48 h |
0 |
0 |
1 |
0 |
1 |
0 |
2 |
0 |
|
72 h |
0 |
0 |
0 |
0 |
1 |
0 |
3 |
0 |
|
7 d |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Mean value 24 + 48 + 72 h |
0.00 |
0.00 |
0.67 |
0.00 |
1.00 |
0.00 |
2.33 |
0.00 |
|
Mean value 24 + 48 + 72 h all animals |
1.00 |
0.00 |
|
|
|
|
|
|
|
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:
- weight of evidence
- 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:
- no analytical purity reported
- GLP compliance:
- yes
- Remarks:
- Bezirksregierung, Lüneburg, Germany
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harald Schriever, Kaninchenfarm, Bremervörde, Germany
- Weight at study initiation: 2.4 – 2.8 kg
- Housing: individual housing in a battery of cages, each equipped with a paper roll disposal system
- Diet: Ssniff MÜ ZR (Alleindiät für Zuchtkaninchen), pellets, ad libitum
- Water: drinking water as for human consumption, ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 2 °C
- Humidity (%): 50 -85%
- Photoperiod (hrs dark / hrs light): 12 / 12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: left eye was used as control
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- 24 h (single application without washing)
- Observation period (in vivo):
- 5 days
Reading time points. 30- 60 min, 24, 48 and 72 h - Number of animals or in vitro replicates:
- 3 (sex was not reported)
- Details on study design:
- SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: ophthalmoscope - 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:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- Some definitely hyperhemic blood vessels (grade 1 conjunctival redness) was observed 1 h post treatment in all 3 animals and in 2/3 animals at 24, 48 and 72 h post treatment. In 1/3 animals this reaction was augmented, as diffuse, crimson colour, not easily discernible individual vessels (grade 2 conjunctival redness) were observed at the 24 h reading time point. 48 and 72 h post treatment only a conjunctival redness, graded 1, was observed. Chemosis was observed in 2/3 animals (grade 1 conjunctival chemosis) at 24 h post treatment, which was fully reversible within 48 h post treatment. All above mentioned effects resulted to be fully reversible latest within 5 days post treatment.
- Other effects:
- No further effects occurred.
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
- Conclusions:
- CLP: not classified
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Lack of data on test substance.
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: Kleinrusse, Chbb:HM
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Thomae, Biberach, Germany
- Age at study initiation: adult
- Weight at study initiation: 2.5 kg
- Housing: The animals were single housed in rabbit cages.
- Diet: Altromin 2023, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 7 d
ENVIRONMENTAL 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 d
Reading 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 system
TOOL USED TO ASSESS SCORE: fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- other: mean out of all 4 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- other: mean out of all 4 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- other: mean out of all 4 animals
- Time point:
- 24/48/72 h
- Score:
- 0.08
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- other: mean out of all 4 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- The application of the test substance to one eye of each animal did not result in corneal opacity, iritis or swelling of the conjunctivae at any observation time point. Very slight redness of the conjunctivae was observed in 1/4 animals at the 24 h reading time point. The effect was reversible within 48 h after the application of the test substance.
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
- Conclusions:
- CLP: not classified
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Irritation
Justification for read-across
There is no data available regarding skin or eye irritation for the target substance Fatty acids, C8-10, oxybis(2-hydroxy-3,1-propanediyl) esters (CAS 92044-91-2). Therefore, read across from the relevant source substances Hexanedioic acid, mixed esters with decanoic acid, 12 -hydroxyoctadecanoic acid, isostearic acid, octanoic acid, 3,3'-oxybis[1,2-propanediol] and stearic acid (CAS 130905-60-1) and 1,2,3-Propanetriol, homopolymer, diisooctadecanoate (CAS 63705-03-3) was applied to obtain information regarding irritating or corrosive potential.
Read-across from appropriate substances is conducted in accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.5. in order to fulfil the standard data requirements defined in Regulation (EC) No 1907/2006, Annex VIII, 8.1 and 8.2. 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 130905-60-1
A skin irritation study was performed with the test substance according to OECD guideline 404 (Sasol, 1990). The clipped skin of the back of 3 New Zealand White rabbits was exposed to 0.5 mL of the test substance for 4 h under semiocclusive conditions. The rabbits were observed for 3 days. Skin reactions were assessed using the Draize scoring system 30 - 60 min, 24, 48 and 72 h after patch removal. The mean scores for erythema and edema (24/48/72 h) were 0.0, indicating that the test substance is not irritating to the skin.
CAS 63705-03-3
A skin irritation study was performed with the test substance equivalent or similar to OECD guideline 404 (BASF, 1988). The shaved skin of the back of 4 male rabbits (Kleinrusse) was exposed to 0.5 mL of the undiluted test substance for 4 h under occlusive conditions. The rabbits were observed for 7 days. Skin reactions were assessed using the Draize scoring system 1, 24, 48 and 72 h and 7 d after patch removal. Very slight to slight erythema formation was observed in 3/4 animals at the 24 and 48 h reading time points. At the 72 h reading time point, slight and moderate erythema formation was observed in 2/4 animals. The mean score for erythema (24/48/72 h) was 1.0, which was fully reversible within 7 days and for edema (24/48/72 h) 0.0. These results indicate that the test substance is not irritating to the skin.
There is data from a Human Patch Test similar to the Guidelines for the Assessment of Skin Tolerance of Potentially Irritant Cosmetic Ingredients (COLIPA, 1997) (BASF, 1997). The test substance was applied at a concentration of 20% for 24 h onto the backs of 20 volunteers in an occlusive manner. The reading time points were 6, 24, 48 and 72 h after removal of the test substance. Exposure to the test substance led to slight erythema in 3/20 volunteers and slight scaling in 2/20 volunteers. The mean scores after 6, 24, 48 and 72 h were 0.15 for erythema and 0.25 for erythema, edema, scaling and fissure. The skin compatibility of the test substance was enhanced compared to the positive control 1% Texapon N25 and 0.5% SDS.
Based on the available human data the test substance is considered not to be irritating to the skin.
Eye irritation
CAS 130905-60-1
An eye irritation study was performed with the test substance according to OECD guideline 405 (Sasol, 1990). 3 New Zealand White rabbits were treated with 0.1 mL of the undiluted test substance. The untreated eye served as control and the eyes of the animals were not washed out. The animals were observed for 5 days with reading time points at 30 - 60 min, 24, 48 and 72 h after application. The application of the test substance to one eye of each animal did not result in corneal opacity or iritis at any observation time point. Some definitely hyperhemic blood vessels (grade 1 conjunctival redness) was observed 1 h post treatment in all 3 animals and in 2/3 animals at 24, 48 and 72 h post treatment. In 1/3 animals this reaction was augmented, as diffuse, crimson colour, not easily discernible individual vessels (grade 2 conjunctival redness) were observed at the 24 h reading time point. 48 and 72 h post treatment only a conjunctival redness, graded 1, was observed. Chemosis was observed in 2/3 animals (grade 1 conjunctival chemosis) at 24 h post treatment, which was fully reversible within 48h post treatment. All above mentioned effects resulted to be fully reversible latest within 5 days post treatment. In conclusion, mean cornea opacity and iris scores of 0.0, a mean conjunctivae score of 1.11 and a mean chemosis score of 0.22 were obtained. Based on these results the test substance is not regarded as eye irritant.
CAS 63705-03-3
An eye irritation study was performed with the test substance equivalent or similar to OECD guideline 405 (BASF, 1988). 4 male rabbits (Kleinrusse) were treated with 0.1 mL of the undiluted test substance. The untreated eye served as control and the eyes of the animals were not washed out. The animals were observed for 3 days with reading time points at 1, 6, 24, 48 and 72 h after application. The application of the test substance to one eye of each animal did not result in corneal opacity, iritis or swelling of the conjunctivae at any observation time point. Very slight redness of the conjunctivae was observed in 1/4 animals at the 24 h reading time point. The effect was reversible within 48 h after the application of the test substance. Thus, mean scores of cornea opacity, iris and chemosis of 0.0 was obtained and a mean conjunctivae score of 0.08. Based on these results the test substance is not regarded as eye irritant.
The available data on skin and eye irritation after application of the two analogue substances (CAS 130905-60-1 and CAS 63705-03-3) do not meet the criteria for classification according to Regulation (EC) 1272/2008.
Justification for classification or non-classification
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.
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