Registration Dossier
Registration Dossier
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EC number: 220-518-2 | CAS number: 2788-26-3
Endpoint summary
Administrative data
Description of key information
Valid in-vivo studies for skin irritation/corrosion and eye irritation are available. No adverse effects are observed for skin- and eye irritation.
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Principles of method if other than guideline:
- 500 µl Phosphono succinic acid tetramethylester were semiocclusively applied once to the intact skin (ear) of two young adult New Zealand white rabbits (3.0–4.0 kg) for an exposure period of 24 hours. Evaluation of skin irritation was made until day 7 according to Draize.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 500 µl
- Duration of treatment / exposure:
- 24 houts
- Observation period:
- 7 days
- Number of animals:
- 2 rabbits
- Details on study design:
- After 24 hours the test material was removed with water and soap.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: score = 0 at any time point
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: score = 0 at any time point
- Irritant / corrosive response data:
- not irritant
- Other effects:
- No other effects reported.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance proved to be not irritating.
- Executive summary:
500 µl Phosphono succinic acid tetramethylester were semiocclusively applied once to the intact skin (ear) of two young adult New Zealand white rabbits (3.0–4.0 kg) for an exposure period of 24 hours. Evaluation of skin irritation was made until day 7 according to Draize. Erythema and edema score = 0 at 24/48/72 hours. The test substance proved to be not irritating.
Reference
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Principles of method if other than guideline:
- A dose of 100 µl Phosphono succinic acid tetramethylester was administered into one eye of two young adult New Zealand white rabbits (3–4 kg) for an exposure period of 24 hours. Then the treated eyes were rinsed with sterile water. The contralateral eye remained untreated and served as a control. The eyes were examined and the grade of ocular reaction was recorded until day 7 post administration according to Draize.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 100 µl
- Duration of treatment / exposure:
- After the exposure period of 24 hours the treated eyes were rinsed with sterile water.
- Observation period (in vivo):
- Seven days.
- Number of animals or in vitro replicates:
- Two animals.
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: score = 0 at any time point
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: score = 0 at any time point
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 3
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: score = 0 at any time point
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The mean cornea, iris and chemosis score was 0 at 24/48/72 hours.The mean conjunctivae was 0.66 at 24/48/72 hours; it was fully reversible within 3 days.
- Executive summary:
A dose of 100 µl Phosphono succinic acid tetramethylesterwas administered into one eye of two young adult New Zealand white rabbits (3–4 kg) for an exposure period of 24 hours. Then the treated eyes were rinsed with sterile water. The contralateral eye remained untreated and served as a control. The eyes were examined and the grade of ocular reaction was recorded until day 7 post administration according to Draize. The mean cornea, iris and chemosis score was 0 at 24/48/72 hours.The mean conjunctivae score was 0.66 at 24/48/72 hours; it was fully reversible within 3 days.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Skin irritation/corrosion:
500 µl Phosphono succinic acid tetramethylester were semiocclusively applied once to the intact skin (ear) of two young adult New Zealand white rabbits (3.0–4.0 kg) for an exposure period of 24 hours. Evaluation of skin irritation was made until day 7 according to Draize. Erythema and edema score = 0 at 24/48/72 hours. The test substance proved to be not irritating.
Eye irritation:
A dose of 100 µl Phosphono succinic acid tetramethylesterwas administered into one eye of two young adult New Zealand white rabbits (3–4 kg) for an exposure period of 24 hours. Then the treated eyes were rinsed with sterile water. The contralateral eye remained untreated and served as a control. The eyes were examined and the grade of ocular reaction was recorded until day 7 post administration according to Draize. The mean cornea, iris and chemosis score was 0 at 24/48/72 hours. The mean conjunctivae score was 0.66 at 24/48/72 hours; it was fully reversible within 3 days.
According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is therefore not justified.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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