Registration Dossier

Administrative data

Description of key information

not irritating to skin

irritating, but not corrosive to the eyes

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:
2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Duration of treatment / exposure:
#1: 3 minutes 0,5 ml one animal
#2: 1 hour 0,5 ml three animals
#3: 4 hour 0,5 ml three animals
Observation period:
14 days
Number of animals:
three animals
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Remarks:
F8931, F8941, F8962
Time point:
other: day 14
Score:
ca. 2.17
Max. score:
8
Reversibility:
fully reversible
Remarks on result:
other: normal
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Interpretation of results:
GHS criteria not met
Conclusions:
The substance is not classified as irritating to skin.
Executive summary:

3 Minute exposure: There was no erythema or edema noted at 1 hour following patch removal.

1 hour exposure: Erythema was absent to barely perceptible at 1 hour following patch removal, barely perceptible at 24 hours. absent to barely perceptible at 48 hours, and absent to well defined at 72 hours. Erythema was absent by day 7 and 14. Edema was absent at 1 hour following patch removal and absent to barely perceptible at 24 hours. Edema was absent at 48 and 72 hours, and on days 7 and 14.

4 hour exposure: Erythema was barely perceptible at 1 hour following patch removal and barely perceptible to well defined at 24, 48, 72 hours. Erythema was absent on days 7 and 14. Edema was absent at 1 hour following patch removal, barely perceptible at 24 hours, and absent to barely perceptible at 48 and 72 hours. Edema was absent on days 7 and 14.

Systemic Observations: There were no abnormal physical signs noted during the observation period. All body weight changes were normal.

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:
01.10.2001 - 15.10.2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Controls:
no
Duration of treatment / exposure:
0,1 ml initial instillation
Observation period (in vivo):
1, 24, 48, 72 hours and on days 7 and 14
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: mini-Maglite
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2.7
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.7
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible

Score at time point / Reversibility

Cornea

Iris

Conjunctivae

Chemosis

Discharge

 

Max. score: 4

Max. score: 2

Max. score: 3

Max. score: 4

Max. score: 3

60 min

0h/0/0

0/0/0

1/2/2

2/3/3

2/2/2

24 h

0h/0h/0h

1/1/1

2/2/2

2/3/2

2/2/2

48 h

0h/2/0h

0/1/0

2/2/2

2/3/2

1/2/2

72 h

0/2/0

0/1/0

2/2/1

2/2/1

1/2/1

7 d

0/0/0

0/0/0

1/1/1

0/1/0

0/1/0

14 d

0/0/0

0/0/0

0/0/0

0/0/0

0/0/0

Average 24h, 48h, 72h

0/1.3/0

0.3/1/0.3 

2/2/1.7 

2/2.7/1.7

1.3/2/1.7

 

h = lack of normal luster

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
2,4,7,9-tetramethyldecane-4,7-diol is an ocular irritant, but not corrosive.
Executive summary:

Ocular findings:

Corneal opacity was noted in 1/3 eyes, although fluorescein stain retention was noted in all the eyes.

The opacity cleared by day 7.

Iritis, noted in 3/3 eyes, cleared by day 7. Conjunctival irritation, noted in 3/3 eyes, cleared by day 14.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

In a primary dermal irritation study according to OECD TG 404 young adult New Zealand White rabbits were dermally exposed to 0.5 mL 2,4,7,9-tetramethyldecane-4,7-diol (3 minutes exposure: one animal; 1 hour exposure: three animals; 4 hour exposure: three animals). Animals then were observed for 14 days.  Irritation was scored by the method of Draize.

3 Minute exposure: There was no erythema or edema noted at 1 hour following patch removal.

1 hour exposure: Erythema was absent to barely perceptible at 1 hour following patch removal, barely perceptible at 24 hours. absent to barely perceptible at 48 hours, and absent to well defined at 72 hours. Erythema was absent by day 7 and 14. Edema was absent at 1 hour following patch removal and absent to barely perceptible at 24 hours. Edema was absent at 48 and 72 hours, and on days 7 and 14.

4 hour exposure: Erythema was barely perceptible at 1 hour following patch removal and barely perceptible to well defined at 24, 48, 72 hours. Erythema was absent on days 7 and 14. Edema was absent at 1 hour following patch removal, barely perceptible at 24 hours, and absent to barely perceptible at 48 and 72 hours. Edema was absent on days 7 and 14.

Systemic Observations: There were no abnormal physical signs noted during the observation period. All body weight changes were normal.

The substance is not irritating to skin.

 

Eye irritation

The purpose of this test was to determine the irritant and/or corrosive effects, if any, of a test article when instilled into the rabbit eye.

Three healthy New Zealand White rabbits (males), free from evidence of ocular irritation and corneal abnormalities, were dosed with 2,4,7,9-tetramethyldecane-4,7-diol. The test article (0.1 ml) was placed into the conjunctival sac of one eye of each rabbit. Sodium fluorescein dye procedures were used at the 24, 48, and 72-hour observation intervals and again on Days 7 and 14. The eyes were examined and scored by the Draize technique at 1,24,48, and 72 hours post-dose and on Days 7 and 14. The primary eye irritation score for each rabbit, each day, was calculated. Body weights were recorded pretest.

Corneal opacity was noted in 1/3 eyes (average score 1.3), although fluorescein stain retention was noted in all the eyes. The opacity cleared by Day 7. Iritis, noted in 3/3 eyes (average scores: 0.3/1/0.3), cleared by Day 7. Conjunctival redness, noted in 3/3 eyes (average scores: 2/2/1.7), cleared by Day 14. Chemosis noted in 3/3 eyes (average scores: 2/2.7/1.7), cleared by Day 14.

The substance is an ocular irritant, but not corrosive.

 

Respiratory irritation

No data on the respiratory irritation of 2,4,7,9-tetramethyldecane-4,7-diol are available.

 

There are no data gaps for the endpoint irritation/corrosion. No human information is available for this endpoint. However, there is no reason to believe that these results would not be applicable to humans.

Justification for classification or non-classification

According to the UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Part 3 Chapter 3.3 it is classified to be irritating to eye.