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Description of key information

Skin, OECD 404, rabbit: not irritating
Eye, OECD 405, rabbit: 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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions. The exposure time was 24 h, no experimental 48 h reading performed, occlusive exposure, the analytical purity of the test substance was not specified.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
24 h exposure time, no experimental 48 h reading, occlusive exposure
GLP compliance:
not specified
Species:
rabbit
Strain:
other: New Zealand
Type of coverage:
occlusive
Preparation of test site:
other: shaved and abraded
Vehicle:
unchanged (no vehicle)
Controls:
other: not required, untreated sites of the same animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 mL
Duration of treatment / exposure:
24 h
Observation period:
72 h
Reading time points: 24 and 72 h
Number of animals:
6 males
Irritation parameter:
erythema score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
24/48/72 h
Score:
ca. 0.7
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: No 48 h values are available: for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h)
Irritation parameter:
edema score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: reversibility not applicable
Remarks on result:
other: No 48 h values are available: for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h)
Remarks:
: for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h)
Irritant / corrosive response data:
Intact skin:
In 6/6 rabbits, very slight to well defined erythema was noted at the 24-hour reading time point (score 1-2). The skin irritation effects were completely reversible within 72 h. No edema was observed in any animal.

Abraded skin:
In 6/6 rabbits, very slight to well defined erythema was noted at the 24-hour reading time point (score 1-2). The skin irritation effects were completely reversible within 72 h. No edema was observed in any animal.

Table 1. Results of skin irritation study – intact skin

Observation time

Rabbit no.

 

1

2

3

4

5

6

 

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

 

24 h

2

0

1

0

1

0

1

0

1

0

1

0

 

48 h

No experimental values available;for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption)

 

72 h

0

0

0

0

0

0

0

0

0

0

0

0

 

 

Table 2. Calculation of mean scores

 

Rabbit no.

 

1

2

3

4

5

6

 

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

 

Mean value 24 + 48 + 72 h*

1.33

0.00

0.67

0.00

0.67

0.00

0.67

0.00

0.67

0.00

0.67

0.00

 

 

 

* No 48 h values are available: for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects over 24 h and 48 h)

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified
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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given. No details on study protocol given; the analytical purity of the test substance is not specified.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
no details on study protocol; analytical purity of the test substance not specified
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Controls:
other: not required
Duration of treatment / exposure:
single application without washing
Observation period (in vivo):
72 h
Reading time points: 1, 24, 48 and 72 h and 7 days
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: Draize scoring system
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of all 3 animals
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
of all 3 animals
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
2
Reversibility:
other: reversibility not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 1.67
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0.67
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 1
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritant / corrosive response data:
3/3 rabbits had some or obvious chemosis and severe redness (conjunctivae, score 3 of 3) at the 1-hour reading time point (see Table 1). 24 hours after instillation of the test substance, 1/3 rabbits still exhibited some chemosis, which had cleared completely within 48 hours. The severity of the redness was slightly reduced in 2/3 rabbits and remained unchanged in 1/3 rabbits at the 24-hour reading time point. The chemosis was completely reversible within 72 hours. No effects on the cornea or iris were noted at any time point.

Table 1: individual irritation scores

 

Rabbit #

 

Time

 

conjunctivae

 

iris

 

cornea

 

redness

chemosis

1

 

 

 

 

1 h

3

1

0

0

24 h

3

0

0

0

48 h

2

0

0

0

72 h

0

0

0

0

Average*

1.67

0.0

0.0

0.0

2

 

 

 

 

1 h

3

1

0

0

24 h

2

0

0

0

48 h

0

0

0

0

72 h

0

0

0

0

Average*

0.67

0.0

0.0

0.0

3

 

 

 

 

1 h

3

2

0

0

24 h

2

 1

0

0

48 h

1

0

0

0

72 h

0

0

0

0

Average*

1.00

0.33

0.0

0.0

* mean of 24 + 48 + 72 h

 

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

 

CAS 59219-71-5

A skin irritation study was performed with 3,5,5-trimethylhexyl 3,5,5-trimethylhexanoate (CAS 59219-71-5) according to a protocol similar to OECD guideline 404 (Masson, 1986). The shaved skin of 6 rabbits was exposed to 0.5 mL undiluted test material for 24 hours under occlusive conditions. The skin irritation effects were evaluated 24 and 72 hours after patch removal. At the 24-hour reading time point, very slight erythema (score 1) was noted in 5/6 rabbits and well-defined erythema (score 2) in 1/6 rabbits, respectively. All skin irritation effects had cleared completely within 72 hours after the exposure ended. The mean erythema scores (over 24, 48 and 72 hours) per animal were 1.33, 0.67, 0.67, 0.67, 0.67 and 0.67, respectively. No edema was observed in any animal, leading to mean edema scores (over 24, 48 and 72 hours) of 0. The test substance is not considered to be irritating to the skin.

Eye irritation

 

CAS 59219-71-5

An acute eye irritation study was performed with 3,5,5-trimethylhexyl 3,5,5-trimethylhexanoate (CAS 59219-71-5) according to a protocol similar to OECD guideline 405 (Dufour, 1990). 0.1 mL of the test substance was instilled into the eyes of 3 New Zealand White rabbits. The animals were observed for 72 hours and scoring was performed 1, 24, 48 and 72 h after instillation. 3/3 rabbits had slight to moderate chemosis (score 1 – 2) and severe redness (conjunctivae, score 3) at the 1-hour reading time point. At the 24-hour reading time point 1/3 rabbits had slight chemosis (score 1). The redness had reduced in severity 24 and 48 hours after instillation, and cleared completely within the 72-hour reading time point. The mean chemosis scores were 0, 0 and 0.33, respectively, and the effect was completely reversible within 48 hours. The conjunctivae mean scores were 1.67, 0.67 and 1.00, respectively. No effects on the cornea or iris were noted in any animal at any time point. The test substance is not considered to be irritating to the eye.

Overall conclusion for skin and eye irritation

The available data on 3,5,5-trimethylhexyl 3,5,5-trimethylhexanoate did not show skin or eye irritation effects. Therefore, 3,5,5-trimethylhexyl 3,5,5-trimethylhexanoate is not considered to be a skin irritant or an eye irritant.


Justification for selection of skin irritation / corrosion endpoint:
The key study was selected.

Justification for selection of eye irritation endpoint:
The key study was selected.

Justification for classification or non-classification

The available data on skin and eye irritation do not meet the classification criteria according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.

 

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