Registration Dossier
Registration Dossier
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EC number: 213-758-4 | CAS number: 1008-72-6
Endpoint summary
Administrative data
Description of key information
Sodium 2 -formylbenzenesulphonate is not skin or eye irritating according to the CLP Regulation (EC n. 1272/2008).
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:
- December 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted according to internationally accepted testing guidelines, not GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: HC: NZW, Fa. Hacking & Churchill ltd., Huntingdon, UK
- Weight at study initiation: average weight for each animal: about 3 kg.
- Housing: in air-conditions room in individual cages
- Diet: ad libitum
- Water: ad libitum (drinking water)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21 °C
- Humidity (%): 40-50 %
- Photoperiod (hrs dark / hrs light): The light/dark cycle was 12 hours per day (artificial light from 7 till 19 h).
- Type of coverage:
- not specified
- Preparation of test site:
- clipped
- Vehicle:
- other: water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 g of the test material dissolved in water
- Duration of treatment / exposure:
- Substance was applied for 4h with a dressing then dressing was removed and the treated zone was washed with water.
- Observation period:
- 7 days. The effects were recorded after 1h, 24h, 48h and till 7 days after treatment.
- Number of animals:
- 3 albino rabbits
- Details on study design:
- TEST SITE
- Area of exposure: 6 X 6 cm (one flank)
- % coverage: 2.5 x 2.5 cm (gauze)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): after 4 h of exposure
OBSERVATION TIME POINTS
(indicate if minutes, hours or days): observation after 1, 24, 48, 72 h and then after 7 days.
SCORING SYSTEM:
- Method of calculation: DRAIZE, J.H.; The Apptaisal of Chemicals in Foods, Drugs, and Cosmetics, pp. 46 - 48. Association of Food and Drug Officials of the United States, Austin, Texas 1959). Ref. OECD Guideline No. 404. - Irritation parameter:
- erythema score
- Basis:
- other: animal 13
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- other: animal 14
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- other: animal 15
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- other: animal 13
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- other: animal 14
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- other: animal 15
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- The observation after 24h, 48h, 72h and 7 days showed no sign of erythema or edema for none of the three rabbits.
- Interpretation of results:
- other: not skin irritant according to the CLP Regulation (EC n.1272/2008)
- Conclusions:
- The substance is not skin irritating according to the CLP Regulation (EC n. 1272/2008).
- Executive summary:
The substance has been tested for skin irritation on three albino rabbits.
The study was conducted according to the OECD Guideline N. 404. The exposure time of the substance was 4 hours. The observation after 24h, 48h, 72h and 7 days showed no sign of erythema or edema for none of the three rabbits. The substance is not skin irritating according to the CLP Regulation (EC n. 1272/2008).
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:
- December 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted according to internationally accepted testing guidelines, not GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: HC: NZW, Fa. Hacking & Churchill ltd., Huntingdon, UK
- Weight at study initiation: average weight for each animal: about 3 kg
- Housing: in air-conditions room in individual cages
- Diet: ad libitum
- Water: ad libitum (drinking water)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21 °C
- Humidity (%): 40-50 %
- Photoperiod (hrs dark / hrs light): The light/dark cycle was 12 hours per day (artificial light from 7 till 19 h). - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 g of solid substance - Duration of treatment / exposure:
- The test sample was applied into the conjunctival sac of one eye of each rabbit.The upper and lower eyelids were held together for several seconds, to avoid any loss of test sample.
- Observation period (in vivo):
- 7 days. The effects were recorded after 1h, 24h, 48h and till 7 days after treatment.
- Number of animals or in vitro replicates:
- 3 males albino rabbits.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): 24 hours after testing the treated eye was washed with saline solution.
SCORING SYSTEM: DRAIZE,J.H.; The Appraisal of the Safety of Chemicals in Foods, Drugs, and Cosmetics, pp. 49 - 52. Association of Food and Drug Officials of the United States, Topeka,Kansas, 1965
TOOL USED TO ASSESS SCORE: Ophthalmoscopy. For the assessment of damages a drop of fluorescein solution was put in the eye, the eye was washed and then was examined by UV-light. - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: Eye rinsed after 24h from application
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: Eye rinsed after 24h from application
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: Eye rinsed after 24h from application
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: Eye rinsed after 24h from application
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: Eye rinsed after 24h from application
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: Eye rinsed after 24h from application
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- other: Eye rinsed after 24h from application
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- other: Eye rinsed after 24h from application
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0.66
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- other: Eye rinsed after 24h from application
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: Eye rinsed after 24h from application.
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: Eye rinsed after 24h from application
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- >= 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: Eye rinsed after 24h from application
- Irritant / corrosive response data:
- The only adverse effects observed during the study were:
- redness (level 1) 24h after exposure only in animal 3 that was fully reversible after 72h
- some liquid excretion from the eye of each of three animals 1h after exposure but fully reversible after 24h for all animals.
The observation after 24h, 48h, 72h and 7 days showed no sign of cornea opacity, no effect on iris and no chemosis for none of the three rabbits. - Interpretation of results:
- other: not eye irritant according to the CLP Regulation (EC n.1272/2008)
- Conclusions:
- The substance is not eye irritating according to the CLP Regulation (EC n. 1272/2008).
- Executive summary:
The substance has been tested for eye irritation on three male albino rabbits.
The study was conducted according to the OECD Guideline N. 405. The eye treated was washed 24h after exposure with saline solution.
The only adverse effects observed during the study were:
- redness (level 1) 24h after exposure only in animal 3 that was fully reversible after 72h
- some liquid excretion from the eye of each of three animals 1h after exposure but fully reversible after 24h for all animals.
The observation after 24h, 48h, 72h and 7 days showed no sign of cornea opacity, no effect on iris and no chemosis for none of the three rabbits.
The substance is not eye irritating according to the CLP Regulation (EC n. 1272/2008).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation/Corrosion
Sodium 2-formylsulphonate has been tested for skin irritation on three albino rabbits.
The study was conducted according to the OECD Guideline N. 404. The exposure time of the substance was 4 hours. The observation after 24h, 48h, 72h and 7 days showed no sign of erythema or edema for none of the three rabbits.
Eye irritation
Sodium 2-formylsulphonate has been tested for eye irritation on three male albino rabbits.
The study was conducted according to the OECD Guideline N. 405. The eye treated was washed 24h after exposure with saline solution.
The only adverse effects observed during the study were:
- redness (level 1) 24h after exposure only in animal 3 that was fully reversible after 72h
- some liquid excretion from the eye of each of three animals 1h after exposure but fully reversible after 24h for all animals.
The observation after 24h, 48h, 72h and 7 days showed no sign of cornea opacity, no effect on iris and no chemosis for none of the three rabbits.
Conclusion
The substance is not skin or eye irritating according to the CLP Regulation (EC n. 1272/2008).
Justification for classification or non-classification
Based on above studies, there is no concern regardin skin/eye irritation for Sodium 2-formylsulphonate
The substance is not skin or eye irritating according to the CLP Regulation (EC n. 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.
