Registration Dossier
Registration Dossier
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: 248-688-3 | CAS number: 27841-06-1
Endpoint summary
Administrative data
Description of key information
Skin irritation / corrosion: in vivo (equivalent/similar to OECD 404): not irritating
Eye irritation / serious eye damage: in vivo (equivalent/similar to OECD 405): 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:
- 05 - 08 Sep 1990
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- 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 2015
- Deviations:
- yes
- Remarks:
- occlusive wrapping used
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hare-Marland, Hewitt, USA
- Age at study initiation: adult animals
- Housing: animals were housed individually in cages
- Diet: Purina Certified Rabbit RationR, ad libitum
- Water: fresh tap water, ad libitum (analyses were performed)
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- 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: 0.5 mL /site - Duration of treatment / exposure:
- 4 h
- Observation period:
- 3 days
Reading time points: 0.5 - 1, 24, 48 and 72 h - Number of animals:
- 3 males and 3 females
- Details on study design:
- TEST SITE
- Type of wrap: gauze patches were applied to each site. The trunk of the animals was then covered with a rubber dam and wrappped with an elastic bandage to retard evaporation.
SCORING SYSTEM: Draize scoring system - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0.11
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritant / corrosive response data:
- 2/6 animals (1 female and 1 male) showed very slight erythema (score 1) after 30 - 60 min, which was fully reversible after 24 h in the male and after 48 h in the female. In 1 other male a very slight erythema was observed at the 24-hour reading time point, which was reversed until the next reading at 48 h.
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
Reference
Table 1: Results of skin irritation study
Rabbit |
Male |
Female |
||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
|||||||
Observation time [h] |
E |
O |
E |
O |
E |
O |
E |
O |
E |
O |
E |
O |
0.5 - 1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
24 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
48 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
72 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Mean value (24 / 48/ 72 h) |
0 |
0 |
0.33 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0.33 |
0 |
Mean value erythema |
0.11 |
|||||||||||
Mean value oedema |
0.00 |
|||||||||||
E = erythema
O = oedema
The mean is calculated only for the values 24 -72 h.
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:
- key study
- Study period:
- 10 - 13 Sep 1990
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- The analytical purity of the test substance was not specified.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- other: Dose selection according to EPA Federal Register, Vol. 50, No. 188, Friday , September 27, 1985
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hare-Marland, Hewitt, USA
- Age at study initiation: adult animals
- Housing: animals were housed individually in cages
- Diet: Purina Lab Rabbit ChowR, ad libitum
- Water: fresh tap water, ad libitum (analyses were performed)
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 - 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 application without washing
- Observation period (in vivo):
- 72 h
Reading time points: 1, 24, 48 and 72 h - Number of animals or in vitro replicates:
- 3 males and 3 females
- Details on study design:
- SCORING SYSTEM: Draize scoring system
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- iris score
- Basis:
- other: each of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0.1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritant / corrosive response data:
- At the 1-hour reading time point, 4/6 animals showed conjunctivae (score 2), which disappeared after 24 h in 1/4 animals and was attenuated (score 1) in 3/4 animals. In 2/4 animals slight conjunctivae (score 1) was observed at the 1-hour reading time point, which remained stable until 24 h in one of the 2 animals and was augmented (score 2) in the other animal. The effects had cleared completely within 48 h.
At the 1-hour reading time point, 2/6 animals showed slight swelling (chemosis), which was reversed after 24 h in one and after 48 h in the other animal.
No further eye irritation effects (opacity or effect on iris) were observed in any rabbit at any time point. - Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
Reference
Table 1: Individual scores of eye irritation
rabbit # |
time [h] |
conjunctivae |
iris |
cornea |
||
redness |
chemosis |
|||||
male |
1 |
1 |
2 |
0 |
0 |
0 |
24 |
1 |
0 |
0 |
0 |
||
48 |
0 |
0 |
0 |
0 |
||
72 |
0 |
0 |
0 |
0 |
||
mean |
0.3 |
0.0 |
0.0 |
0.0 |
||
2 |
1 |
2 |
0 |
0 |
0 |
|
24 |
1 |
0 |
0 |
0 |
||
48 |
0 |
0 |
0 |
0 |
||
72 |
0 |
0 |
0 |
0 |
||
mean |
0.3 |
0.0 |
0.0 |
0.0 |
||
3 |
1 |
2 |
1 |
0 |
0 |
|
24 |
0 |
0 |
0 |
0 |
||
48 |
0 |
0 |
0 |
0 |
||
72 |
0 |
0 |
0 |
0 |
||
mean |
0.0 |
0.0 |
0.0 |
0.0 |
||
female |
4 |
1 |
1 |
0 |
0 |
0 |
24 |
2 |
0 |
0 |
0 |
||
48 |
0 |
0 |
0 |
0 |
||
72 |
0 |
0 |
0 |
0 |
||
mean |
0.7 |
0.0 |
0.0 |
0.0 |
||
5 |
1 |
1 |
1 |
0 |
0 |
|
24 |
1 |
1 |
0 |
0 |
||
48 |
0 |
0 |
0 |
0 |
||
72 |
0 |
0 |
0 |
0 |
||
mean |
0.3 |
0.3 |
0.0 |
0.0 |
||
6 |
1 |
2 |
0 |
0 |
0 |
|
24 |
1 |
0 |
0 |
0 |
||
48 |
0 |
0 |
0 |
0 |
||
72 |
0 |
0 |
0 |
0 |
||
mean |
0.3 |
0.0 |
0.0 |
0.0 |
||
m/f |
1 - 6 |
total mean |
0.3 |
0.1 |
0.0 |
0.0 |
The mean is calculated only for the values 24 -72 h.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
The skin irritation potential of neopentyl glycol dicaprate (CAS 27841-06-1) was investigated in a primary skin irritation study similar or equivalent to OECD guideline 404 and under GLP conditions (Pharmakon, 1990b). Three New Zealand White rabbits per sex were exposed to 0.5 mL of the unchanged test material. The test sites were clipped and the exposure took place for 4 h under occlusive conditions. Gauze patches were applied to each site. The trunk of the animals was covered with a rubber patch and wrapped with an elastic bandage to reduce evaporation. Animals were observed for 3 days and skin reactions were scored according to the Draize system at 0.5 - 1, 24, 48 and 72 h after removal of the patches. 2/6 animals (1 female and 1 male) showed very slight erythema (score 1) after 0.5 - 1 h, which was fully reversible after 24 h in the male and after 48 h in the female. In one other male a very slight erythema was observed at the 24 h reading time point, which had cleared within next reading time point at 48 h. No further skin reactions were recorded.
Eye irritation
Neopentyl glycol dicaprate (CAS 27841-06-1) was tested for its eye irritating properties in a study similar or equivalent to OECD guideline 405 and under GLP conditions (Pharmakon, 1990c). 0.1 mL of the undiluted test item was instilled into the conjunctival sac of three male and three female New Zealand White rabbits. The animals were observed for 3 days. Eye irritation was scored according to the Draize system 1, 24, 48 and 72 h after application. At the 1 h reading time point, 4/6 animals showed conjunctivae (score 2), which disappeared after 24 h in 1/4 animals and was attenuated (score 1) in 3/4 animals. In 2/4 animals slight conjunctivae (score 1) was observed at the 1 h reading time point. At the 24-h time point, the severity remained the same (score 1) in one of the 2 animals and the severity increased (score 2) in the second animal with conjunctivae. The effects had cleared completely within 48 h. At the 1 h reading time point, 2/6 animals showed slight swelling (chemosis), which was reversed after 24 h in one and after 48 h in the other animal. No further eye irritation effects (opacity or effect on iris) were observed in any rabbit at any time point.
Conclusion on skin and eye irritation
Adequate and reliable in vivo investigations performed with the target substance indicate a very low irritation potential and no hazard for skin and eye irritation is identified. No classification as skin or eye irritant is required.
Justification for classification or non-classification
The available data on skin and eye irritation of the target substance neopentyl glycol dicaprate (CAS 27841-06-1) do not meet the classification criteria according to the CLP Regulation (EC) No. 1272/2008. Data 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.
