Registration Dossier

Administrative data

Description of key information

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:
8 February 1988 to 20 July 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study in accordance with internationally recognised guideline
Qualifier:
according to
Guideline:
EPA OTS 798.4470 (Acute Dermal Irritation)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Remarks:
Eau (0,5 ml)
Controls:
no
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
6
Irritation parameter:
erythema score
Basis:
mean
Score:
0
Max. score:
0
Remarks on result:
other: Max. duration: d; Max. value at end of observation period: 0
Irritation parameter:
edema score
Basis:
mean
Score:
0
Max. score:
0
Remarks on result:
other: Max. duration: d; Max. value at end of observation period: 0

Animal

Sex

Observation interval

30-60 min

24 h

48 h

72 h

Erythema

1

M

0

0

0

0

2

M

0

0

0

0

3

M

0

0

0

0

4

F

0

0

0

0

5

F

0

0

0

0

6

F

0

0

0

0

Edema

1

M

0

0

0

0

2

M

0

0

0

0

3

M

0

0

0

0

4

F

0

0

0

0

5

F

0

0

0

0

6

F

0

0

0

0

Interpretation of results:
other: not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
No mortality occurred during the study. There was no erythema, edema or any other dermal effects noted at any time during the study. Based
on the results of the study, Phosphorous acid, neopentanetetrayl bis (2,6-di-tert-butyl-4-methylphenyl) ester is not a dermal irritant .
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:
8 February 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study in accordance with internationally recognised guideline
Qualifier:
according to
Guideline:
EPA OTS 798.4500 (Acute Eye Irritation)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
.1 ML
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
6
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Score:
0.11
Max. score:
1
Remarks on result:
other: Max. duration: 24 h; Max. value at end of observation period: 0
Irritation parameter:
chemosis score
Basis:
mean
Score:
0.08
Max. score:
1
Remarks on result:
other: Max. duration: 48 h; Max. value at end of observation period: 0
Irritation parameter:
cornea opacity score
Basis:
mean
Score:
0
Max. score:
0
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: 0
Irritation parameter:
iris score
Basis:
mean
Score:
0
Max. score:
0
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: 0
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 3 days

Animal

Sex

Observation period

Cornea

opacity

Iris

Redness

Chemosis

1

M

1 hour

24 hours

48 hours

72 hours

0

0

0

0

0

0

0

0

1

0

0

0

0

0

0

0

2

M

1 hour

24 hours

48 hours

72 hours

0

0

0

0

0

0

0

0

1

1

0
0

1

0

0

0

3

F

1 hour

24 hours

48 hours

72 hours

0

0

0

0

0

0

0

0

1

0

0

0

0

0

0

0

4

M

1 hour

24 hours

48 hours

72 hours

0

0

0

0

0

0

0

0

1

1

0

0

1

0

1

0

5

F

1 hour

24 hours

48 hours

72 hours

0

0

0

0

0

0

0

0

1

0

0

0

0

0

0

0

6

F

1 hour

24 hours

48 hours

72 hours

0

0

0

0

0

0

0

0

1

0

0

0

0

0

0

0

Not classified i.e.:

The substance did not, when applied to the eye of an animal, produce:

At least in 2 of 3 tested animals, a positive response of:

— corneal opacity ≥ 1 and/or

— iritis ≥ 1, and/or

— conjunctival redness ≥ 2 and/or

— conjunctival oedema (chemosis) ≥ 2

Calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, and which fully reverses within an observation period of 21 days.

Interpretation of results:
other: not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Based upon the results of this study, Phosphorous acid, cyclic neopentanetetrayl bis (2,6-di-tert-butyl-4-methylphenyl) ester is considered to be mildly irritating to rabbit eyes.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

No mortality occurred during an in vivo study for dermal irritation. There was no erythema, edema or any other dermal effects noted at any time during the study. Based on the results of the study, the test substance is not a dermal irritant. In an in vivo eye irritation test there were no irreversible effects and any transient effects were not sufficient to warrant classification.


Justification for selection of skin irritation / corrosion endpoint:
Key study

Justification for selection of eye irritation endpoint:
Key study

Justification for classification or non-classification

The substance does not require classifying as, irritating to skin or eyes.