Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 251-908-0 | CAS number: 34274-28-7
Endpoint summary
Administrative data
Description of key information
In the key in vivo skin irritation study, conducted according to OECD Test Guideline 404 and in compliance with GLP, ATMP-xNH4 was applied to the skin of New Zealand White rabbits under semiocclusive coverage. No dermal reactions were observed in any of the animals and it was concluded that the test substance is not a skin irritant under the conditions of the test (SafePharm Laboratories Ltd., 1995; reliability 1).
In the key in vivo eye irritation study, conducted according to OECD Test Guideline 405 and in compliance with GLP, 0.1 mL of undiluted ATMP-xNH4 was applied to the eye of New Zealand White rabbit. One of three rabbits had minimal irritation to one eye and it was concluded that the test substance is not irritating to eyes (SafePharm Laboratories Ltd., 1995; reliability 1).
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:
- 31.03.1995 to 03.04.1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, UK.
- Age at study initiation: 12 to 16 weeks
- Weight at study initiation: 2.3 to 2.61 kg
- Housing: Individually housed in suspended metal cages.
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Minimum five days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-21
- Humidity (%): 56-61
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 31.03.1995 To: 03.04.1995 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml - Duration of treatment / exposure:
- Four hours
- Observation period:
- 72 hours
- Number of animals:
- Three
- Details on study design:
- TEST SITE
- Area of exposure: The back
- % coverage: No stated, but patch was 2.5 x 2.5
- Type of wrap if used: The trunk was wrapped in an elasticated corset.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, with cotton wool soaked in distilled water
- Time after start of exposure: Four hours
SCORING SYSTEM: Draize - Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: all
- Score:
- 0
- Reversibility:
- other: No irritation observed
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- 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
- 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
- Irritant / corrosive response data:
- No dermal reactions observed.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a GLP, skin irritation study (reliability score 1) conducted to OECD 404, undiluted ammonium salt of ATMP (no information on composition of liquid tested) 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:
- 10.04.1995 to 14.04.1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd, Sandbach Cheshire, UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.52 to 2.96 kg
- Housing: Individually in suspended metal cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: minimum five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-21
- Humidity (%): 52-60
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 10.04.1995 To: 14.04.1995 - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml - Duration of treatment / exposure:
- No washing
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- Three
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): No washing
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: standard ophthalmoscope - Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: no data
- Score:
- 1.3
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Minimal conjunctival irritation (grade 1) was noted in one eye at the one and 24 hour observations.
- Other effects:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an eye irritation study, conducted according to OECD Test Guideline 405 and in compliance with GLP, undiluted ammonium salt of ATMP was minimally irritating to one eye in one of three rabbits, so is concluded not to be irritating to eyes.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
In the key in vivo skin irritation study, conducted according to OECD Test Guideline 404 and in compliance with GLP, 0.5 mL of undiluted ATMP-xNH4 was applied to the skin of three New Zealand White rabbits under semiocclusive coverage for four hours. Thereafter, the area was washed with cotton wool soaked in distilled water and observation occurred for 72 hours. No dermal reactions were observed in any of the animals and it was concluded that the test substance is not a skin irritant under the conditions of the test (SafePharm Laboratories Ltd., 1995; reliability 1).
In the key in vivo eye irritation study, conducted according to OECD Test Guideline 405 and in compliance with GLP, 0.1 mL of undiluted ATMP-xNH4 was applied to the eye of three New Zealand White rabbit without any washing. One of three rabbits had minimal conjunctival irritation (grade 1) at the 1 and 24-hour observation. This observation does not upfill the criteria to be classified as an eye irritant so it was concluded that the test substance is not irritating to eyes under the conditions of the test (SafePharm Laboratories Ltd., 1995; reliability 1).
Justification for classification or non-classification
Based on the available data and knowledge of pH of the ammonium salts, ATMP-xNH4 does not require classification for skin or eye irritation/corrosion according to Regulation (EC) No. 1272/2008.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
