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EC number: 229-146-5 | CAS number: 6419-19-8
Endpoint summary
Administrative data
Description of key information
See irritant endpoint summary for discussion on 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:
- 27.07.1982 to 30.07.1982
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Specific details on test material used for the study:
- Composition: 1.5% HCl, 40.2% ATMP-H, 7.1% Me-ADMP-H (phosphonate impurity similar to main constituent), 3.4% phosphonic acid
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- undiluted
- Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- 1, 24, 48 and 72 hours
- Number of animals:
- Three
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.4
- Reversibility:
- fully reversible
- Remarks on result:
- other: No edema observed in any animal. 3/3 animals had grade 1 erythema after one hour, 2/3 had grade 1 erythema after 24 hours. There was no erythema in any animal by 48 hours.
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Other effects:
- None reported.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a skin irritation study (Reliability 1) conducted to OECD 404 and GLP, ATMP-H (CAS 6419-19-8; EC No., 229-146-5; aqueous solution containing 40.2% w/w active acid) was not irritating to the skin of rabbits.
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
- Study period:
- No data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- No details on test substance, animals and environmental conditions.
- Principles of method if other than guideline:
- Method: Insufficient detail to fully assess comparability with OECD test guideline.
- GLP compliance:
- no
- Specific details on test material used for the study:
- Anhydrous sample without details of substance identity.
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- No data
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 100 mg of a finely ground powder
placed into the conjunctival sac of the right eye.
- Duration of treatment / exposure:
- 24 hour(s)
- Observation period (in vivo):
- Seven days
- Number of animals or in vitro replicates:
- Three
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, with warm isotonic saline solution.
- Time after start of exposure: 24 hours.
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: No data - Irritation parameter:
- other: Average maximum score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 53.6
- Max. score:
- 110
- Reversibility:
- not fully reversible within: Seven days
- Remarks on result:
- other: Results given as one overall score per animal, not broken down into effects on cornea/iris/conjunctivae.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Remarks on result:
- other: Results given as one overall score per animal, not broken down into effects on cornea/iris/conjunctivae.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Remarks on result:
- other: Results given as one overall score per animal, not broken down into effects on cornea/iris/conjunctivae.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Remarks on result:
- other: Results given as one overall score per animal, not broken down into effects on cornea/iris/conjunctivae.
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Remarks on result:
- other: Results given as one overall score per animal, not broken down into effects on cornea/iris/conjunctivae.
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Remarks on result:
- other: Results given as one overall score per animal, not broken down into effects on cornea/iris/conjunctivae.
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Remarks on result:
- other: Results given as one overall score per animal, not broken down into effects on cornea/iris/conjunctivae.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Remarks on result:
- other: Results given as one overall score per animal, not broken down into effects on cornea/iris/conjunctivae.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Remarks on result:
- other: Results given as one overall score per animal, not broken down into effects on cornea/iris/conjunctivae.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Remarks on result:
- other: Results given as one overall score per animal, not broken down into effects on cornea/iris/conjunctivae.
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Remarks on result:
- other: Results given as one overall score per animal, not broken down into effects on cornea/iris/conjunctivae.
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Remarks on result:
- other: Results given as one overall score per animal, not broken down into effects on cornea/iris/conjunctivae.
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Remarks on result:
- other: Results given as one overall score per animal, not broken down into effects on cornea/iris/conjunctivae.
- Irritant / corrosive response data:
- Oedema with the lids about half closed, copious discharge, moderate redness of the conjunctivae and mild corneal cloudiness were recorded by one hour after instillation. The lids were nearly closed overnight and there was moderate iris conjunction (24 hours). Improvement followed irrigation so that within five days iris clarity was nearly normal in two animals. Also, discharge had ceased and oedema had reduced considerably.
- Other effects:
- Signs of discomfort or pain were pawing at the eyes.
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- In an in vivo eye irritation study, conducted prior to the adoption of OECD test guidelines and GLP, finely ground powder of ATMP-H (CAS 6419-19-8; EC No., 229-146-5; anhydrous sample without details of substance identity) caused moderately severe eye irritation to rabbit eyes.
Reference
Table 1 Summary of eye irritation scores
| Animal Number | Numerical Evaluation* at the end of: | |||||
| 1 hour | 24 hours | 48 hours | 72 hours | 120 hours | 168 hours | |
| 1 - Male | 32 | 57 | 48 | 39 | 19 | 8 |
| 2 - Female | 25 | 49 | 41 | 31 | 10 | 2 |
| 3 - Male | 27 | 55 | 44 | 29 | 8 | 2 |
| Average | 28.0 | 53.6 | 44.3 | 33.0 | 12.3 | 4.0 |
*Results given as one overall score per animal, not broken down into effects on cornea/iris/conjunctivae.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
See irritant endpoint summary for discussion on additional information.
Justification for classification or non-classification
ATMP-H as sold is an aqueous solution with a solids content of 48-52%; it has a pH of 1-2 as a 1% solution. The low pH means that the substance is irritating to eyes and a classification of Eye Irritation Category 2 (H319: Causes serious eye irritation) applies. However, the substance is often used as part of a formulation with higher pH. The neutral salts of ATMP are not irritating based on measured data. Therefore, a Classification and an Assessment Entity are presented for ATMP-H used as part of a formulation with pH >2. This form of the substance is non-irritating. It is concluded that no classification for skin and eye irritation or corrosion is required for the neutralised form of ATMP-H according to Regulation (EC) No 1272/2008.
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