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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 237-396-1 | CAS number: 13770-89-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- December 1998 to November 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline study.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- According to OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Nickel sulphate
- EC Number:
- 232-104-9
- EC Name:
- Nickel sulphate
- Cas Number:
- 7786-81-4
- Molecular formula:
- NiSO4
- IUPAC Name:
- nickel(2+) sulfate
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Myrtle's Rabbitry, Thompson Station, TN, USA.
- Age at study initiation: Adult
- Weight at study initiation: not reported
- Housing: individually housed
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum of 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21 deg. C
- Humidity (%): 19-50%,
- Air changes (per hr): 10-15 per hour
- Photoperiod: 12-h light/12-h dark photoperiod.
IN-LIFE DATES: not reported
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
VEHICLE: none reported - Duration of treatment / exposure:
- 168 hour(s)
- Observation period (in vivo):
- up to 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Both eyes of each test animal were examined prior to testing to identify any pre-existing ocular irritation or corneal injury. Three rabbits (one
male and two females) were dosed with 0.1 g of the test substance and the eyes were not rinsed. The test article was instilled into the conjunctival
sac of the right eye of each animal, a minimum of 1 hour after preliminary examination. Following instillation, the eyelids were gently held together
for one second to limit test article loss. The untreated left eye of each animal served as the control. Animals were examined twice daily. Body weights were measured prior to dosing. All animals were sacrificed at the end of the study duration. No necropsy examinations were performed.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): using physiological saline
- Time after start of exposure: 24 hours
SCORING SYSTEM: Ocular observations were conducted at 1, 24, 48 and 72 hours and up to 7 days after dosing. Eyes were scored using the EEC Ocular Evaluation Criteria, which is based on Draize (1959).
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 0
- Remarks on result:
- other: non irritant
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 52401
- Remarks:
- male
- Time point:
- other: 1 hr
- Score:
- 0
- Remarks on result:
- other: non irritant
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 52401
- Remarks:
- male
- Time point:
- 24 h
- Score:
- 0
- Remarks on result:
- other: non irritant
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 52401
- Remarks:
- male
- Time point:
- 48 h
- Score:
- 0
- Remarks on result:
- other: non irritant
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 52401
- Remarks:
- male
- Time point:
- 72 h
- Score:
- 0
- Remarks on result:
- other: non irritant
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 52627
- Remarks:
- female
- Time point:
- other: 1 hr
- Score:
- 0
- Remarks on result:
- other: non irritant
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 52627
- Remarks:
- female
- Time point:
- 24 h
- Score:
- 0
- Remarks on result:
- other: non irritant
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 52627
- Remarks:
- female
- Time point:
- 48 h
- Score:
- 0
- Remarks on result:
- other: non irritant
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 52627
- Remarks:
- female
- Time point:
- 72 h
- Score:
- 0
- Remarks on result:
- other: non irritant
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 52525
- Remarks:
- female
- Time point:
- other: 1 hr
- Score:
- 0
- Remarks on result:
- other: non irritant
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 52525
- Remarks:
- female
- Time point:
- 24 h
- Score:
- 0
- Remarks on result:
- other: non irritant
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 52525
- Remarks:
- female
- Time point:
- 48 h
- Score:
- 0
- Remarks on result:
- other: non irritant
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 52525
- Remarks:
- female
- Time point:
- 72 h
- Score:
- 0
- Remarks on result:
- other: non irritant
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 52525
- Remarks:
- female
- Time point:
- 7 d
- Score:
- 0
- Remarks on result:
- other: non irritant
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 0.33
- Reversibility:
- fully reversible
- Remarks on result:
- other: non irritant
- Irritation parameter:
- iris score
- Basis:
- animal: 52401
- Remarks:
- male
- Time point:
- other: 1 hr
- Score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- other: non irritant
- Irritation parameter:
- iris score
- Basis:
- animal: 52401
- Remarks:
- male
- Time point:
- 24 h
- Score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- other: non irritant
- Irritation parameter:
- iris score
- Basis:
- animal: 52401
- Remarks:
- male
- Time point:
- 48 h
- Score:
- 0
- Remarks on result:
- other: non irritant
- Irritation parameter:
- iris score
- Basis:
- animal: 52401
- Remarks:
- male
- Time point:
- 72 h
- Score:
- 0
- Remarks on result:
- other: non irritant
- Irritation parameter:
- iris score
- Basis:
- animal: 52627
- Remarks:
- female
- Time point:
- other: 1 hr
- Score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- other: non irritant
- Irritation parameter:
- iris score
- Basis:
- animal: 52627
- Remarks:
- female
- Time point:
- 24 h
- Score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- other: non irritant
- Irritation parameter:
- iris score
- Basis:
- animal: 52627
- Remarks:
- female
- Time point:
- 48 h
- Score:
- 0
- Remarks on result:
- other: non irritant
- Irritation parameter:
- iris score
- Basis:
- animal: 52627
- Remarks:
- female
- Time point:
- 72 h
- Score:
- 0
- Remarks on result:
- other: non irritant
- Irritation parameter:
- iris score
- Basis:
- animal: 52525
- Remarks:
- female
- Time point:
- other: 1 hr
- Score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- other: non irritant
- Irritation parameter:
- iris score
- Basis:
- animal: 52525
- Remarks:
- female
- Time point:
- 24 h
- Score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- other: non irritant
- Irritation parameter:
- iris score
- Basis:
- animal: 52525
- Remarks:
- female
- Time point:
- 48 h
- Score:
- 0
- Remarks on result:
- other: non irritant
- Irritation parameter:
- iris score
- Basis:
- animal: 52525
- Remarks:
- female
- Time point:
- 72 h
- Score:
- 0
- Remarks on result:
- other: non irritant
- Irritation parameter:
- iris score
- Basis:
- animal: 52525
- Remarks:
- female
- Time point:
- 7 d
- Score:
- 0
- Remarks on result:
- other: non irritant
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 0.67
- Reversibility:
- fully reversible
- Remarks on result:
- other: non irritant
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: 52401
- Remarks:
- male
- Time point:
- other: 1 hr
- Score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- other: non irritant
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: 52401
- Remarks:
- male
- Time point:
- 24 h
- Score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- other: non irritant
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: 52401
- Remarks:
- male
- Time point:
- 48 h
- Score:
- 0
- Remarks on result:
- other: non irritant
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: 52401
- Remarks:
- male
- Time point:
- 72 h
- Score:
- 0
- Remarks on result:
- other: non irritant
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: 52627
- Remarks:
- female
- Time point:
- other: 1 hr
- Score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- other: non irritant
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: 52627
- Remarks:
- female
- Time point:
- 24 h
- Score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- other: non irritant
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: 52627
- Remarks:
- female
- Time point:
- 48 h
- Score:
- 0
- Remarks on result:
- other: non irritant
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: 52627
- Remarks:
- female
- Time point:
- 72 h
- Score:
- 0
- Remarks on result:
- other: non irritant
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: 52525
- Remarks:
- female
- Time point:
- other: 1 hr
- Score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: non irritant
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: 52525
- Remarks:
- female
- Time point:
- 24 h
- Score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: non irritant
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: 52525
- Remarks:
- female
- Time point:
- 48 h
- Score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- other: non irritant
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: 52525
- Remarks:
- female
- Time point:
- 72 h
- Score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- other: non irritant
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: 52525
- Remarks:
- female
- Time point:
- 7 d
- Score:
- 0
- Remarks on result:
- other: non irritant
- Irritation parameter:
- chemosis score
- Remarks:
- edema
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 0.44
- Reversibility:
- fully reversible
- Remarks on result:
- other: non irritant
- Irritation parameter:
- chemosis score
- Remarks:
- edema
- Basis:
- animal: 52401
- Remarks:
- male
- Time point:
- other: 1 hr
- Score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: non irritant
- Irritation parameter:
- chemosis score
- Remarks:
- edema
- Basis:
- animal: 52401
- Remarks:
- male
- Time point:
- 24 h
- Score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- other: non irritant
- Irritation parameter:
- chemosis score
- Remarks:
- edema
- Basis:
- animal: 52401
- Remarks:
- male
- Time point:
- 48 h
- Score:
- 0
- Remarks on result:
- other: non irritant
- Irritation parameter:
- chemosis score
- Remarks:
- edema
- Basis:
- animal: 52401
- Remarks:
- male
- Time point:
- 72 h
- Score:
- 0
- Remarks on result:
- other: non irritant
- Irritation parameter:
- chemosis score
- Remarks:
- edema
- Basis:
- animal: 52627
- Remarks:
- female
- Time point:
- other: 1 hr
- Score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: non irritant
- Irritation parameter:
- chemosis score
- Remarks:
- edema
- Basis:
- animal: 52627
- Remarks:
- female
- Time point:
- 24 h
- Score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- other: non irritant
- Irritation parameter:
- chemosis score
- Remarks:
- edema
- Basis:
- animal: 52627
- Remarks:
- female
- Time point:
- 48 h
- Score:
- 0
- Remarks on result:
- other: non irritant
- Irritation parameter:
- chemosis score
- Remarks:
- edema
- Basis:
- animal: 52627
- Remarks:
- female
- Time point:
- 72 h
- Score:
- 0
- Remarks on result:
- other: non irritant
- Irritation parameter:
- chemosis score
- Remarks:
- edema
- Basis:
- animal: 52525
- Remarks:
- female
- Time point:
- other: 1 hr
- Score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: non irritant
- Irritation parameter:
- chemosis score
- Remarks:
- edema
- Basis:
- animal: 52525
- Remarks:
- female
- Time point:
- 24 h
- Score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: non irritant
- Irritation parameter:
- chemosis score
- Remarks:
- edema
- Basis:
- animal: 52525
- Remarks:
- female
- Time point:
- 48 h
- Score:
- 0
- Remarks on result:
- other: non irritant
- Irritation parameter:
- chemosis score
- Remarks:
- edema
- Basis:
- animal: 52525
- Remarks:
- female
- Time point:
- 72 h
- Score:
- 0
- Remarks on result:
- other: non irritant
- Irritation parameter:
- chemosis score
- Remarks:
- edema
- Basis:
- animal: 52525
- Remarks:
- female
- Time point:
- 7 d
- Score:
- 0
- Remarks on result:
- other: non irritant
- Irritant / corrosive response data:
- Exposure to the test article produced irrititis in 3/3 test eyes at the 1-hour scoring interval.
The irititis resolved completely by 48 hours. Conjunctivitis was noted in 3/3 test eyes at the 1-hour scoring interval.
Conjunctival irritation resolved completely in all test eyes by study day 7.
Based on the results of the test, the test substance is considered a mild irritant to the ocular tissue of the rabbit. - Other effects:
- No other effects were observed.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Conclusions:
- Classification: not irritating
- Executive summary:
STUDY RATED BY AN INDEPENDENT REVIEWER.
ROBUST SUMMARY DEVELOPED BY AN INDEPENDENT REVIEWER.
Robust Summary for SLI (1999):
Adult New Zealand rabbits were obtained from Myrtle's Rabbitry, Thompson Station, TN, USA. Animals were individually housed and provided food and
water ad libitum. Room temperature and humidity were maintained at 19-21 deg. C and 19-50%, respectively. Light exposure was maintained as a 12-h
light/12-h dark photoperiod.
Both eyes of each test animal were examined prior to testing to identify any pre-existing ocular irritation or corneal injury. Three rabbits (onemale and two females) were dosed with 0.1 g of the test substance and the eyes were not rinsed. The test article was instilled into the conjunctival
sac of the right eye of each animal, a minimum of 1 hour after preliminary examination. Following instillation, the eyelids were gently held together
for one second to limit test article loss. The untreated left eye of each animal served as the control.
Ocular observations were conducted at 1, 24, 48 and 72 hours and up to 7 days after dosing. Animals were examined twice daily. Body weights weremeasured prior to dosing. All animals were sacrificed at the end of the study duration. No necropsy examinations were performed.
Eyes were scored using the EEC Ocular Evaluation Criteria, which is based on Draize (1959).
Exposure to the test article produced irrititis in 3/3 test eyes at the 1-hour scoring interval. The irititis resolved completely by 48 hours.Conjunctivitis was noted in 3/3 test eyes at the 1-hour scoring interval. Conjuntival irritation resolved completely in all test eyes by study day 7.
No other effects were observed.
Based on the results of the test, the test substance is considered a mild irritant to the ocular tissue of the rabbit.
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.
