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Registration Dossier
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EC number: 410-290-4 | CAS number: 80693-00-1 ADK STAB PEP-36
Endpoint summary
Administrative data
Description of key information
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:
- 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
- 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
- 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 .
Reference
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 |
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:
- 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
- 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
- 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.
Reference
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 |
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.
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.
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