Registration Dossier

Diss Factsheets

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
Reference
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.

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
(all 6 animals; 24 / 48/ 72 h)

0.11

Mean value oedema
(all 6 animals; 24 / 48/ 72 h)

0.00

E = erythema

O = oedema

The mean is calculated only for the values 24 -72 h.

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
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.

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.

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
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.

Categories Display