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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 610-601-5 | CAS number: 51032-53-2
Endpoint summary
Administrative data
Description of key information
In vivo skin irritation study in rabbits (OECD 404)
In vivo eye irritation study in rabbits (OECD 405)
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:
- 1984
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- May 12, 1981
- Deviations:
- not specified
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414, Fuellinsdorf
- Age at study initiation: 12 - 14 weeks
- Weight at study initiation: 2100-2490 g
- Housing: individually in metal cages
- Diet (e.g. ad libitum): Rabbit food, NAFAG, No. 814 Tox, NAFAG AG, Gossau, SG (Switzerland; ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3° C
- Humidity (%): 30-70 %
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12 / 12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- three females
- Details on study design:
- TEST SITE
- Area of exposure: at least 6 sq. cm
- Type of wrap if used: A gauze patch bearing 0.5 ml of the test substance was applied to the skin and looseli held in place by adhesive but non irritating tape (ISOPLAST AG, CH-5200 Brugg)
OBSERVATION TIME POINTS
- 1, 24, 48 72 hours
SCORING SYSTEM:
- Method of calculation: per guidelines - Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Score:
- 0.5
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: minimal irritation
- Remarks:
- see attached table of results
- Irritant / corrosive response data:
- Grade 2 erythema and Grade 1 oedema was observed in one animal at 1 hour. This animal showed Grade 1 erythema and Grade 1 oedema at 24 hours. A second animal showed Grade 1 erythema at 1 hour. No reactions were seen in the third animal.
- Other effects:
- The animals showed a normal body weight development.
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Not classified by CLP Criteria
- Conclusions:
- In a guideline (OECD 404) in vivo skin irritation study, TGE Phosphite was found to be a non-irritant to intact rabbit skin. The calculated dermal irritation index was 0.5. All reactions cleared within 48 hours.
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:
- 1984
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- May 12. 1981
- Deviations:
- not specified
- GLP compliance:
- yes
- Specific details on test material used for the study:
- TEST MATERIAL NAME (as stated in study report): TK 12184 / 1 (Generic name: TGE - Phosphite)
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Sponsor / Batch No. 004-009
- Expiration date of the lot/batch: November, 1984
- Purity: commercial grade
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG. CB-4414, Fuellinsdorf
- Age at study initiation: 12 - 14 weeks
- Weight at study initiation: 1750-1890 9
- Housing: individually in metal cages
- Diet (e.g. ad libitum): Rabbit food, NAFAG, No. 814 Tox, NAPAG AG, Gossau, SG (Switzerland), ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3° C
- Humidity (%): 30-70 %
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12 / 12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- Single exposure
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3 animals
- Details on study design:
- Scoring system per test guideline
- Irritation parameter:
- other: results
- Remarks on result:
- other: see narrative description below and attached table of results.
- Irritant / corrosive response data:
- No cornea or iris changes were observed.
Conjunctival redness: Grade 2 in all animals at 1 hr, and in one animal at 24 hr. Grade 1 in two animals at 24 hours and one animal at 48 hrs.
Conjunctival oedema: Grade 1 in all animals at 1 hr, and in one animal at 24 hr.
All eyes were normal at 72 hrs. - Other effects:
- The animals showed a normal body weight development.
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Not classified by CLP Criteria
- Conclusions:
- In a guideline (OECD 405) in vivo eye irritation study, TGE Phosphite was mildlly irritating to the rabbit eye. Transient conjunctival redness and chemosis was observed, which did not reach levels for classification as an eye irritant according to CLP criteria. All eyes returned to normal within 72 hr.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In vivo skin irritation (rabbit): minimal irritation, primary irritation index = 0.5. Changes were fully reversible within 48 hours.
In vivo eye irritation (rabbit): mildly irritating. All eyes returned to normal within 72 hours.
Justification for classification or non-classification
Based on the available data, TGE Phosphite is not classified as a skin or eye irritant 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.
