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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 229-764-5 | CAS number: 6712-98-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2 Feb to 9 Feb 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline study, to GLP, with slight deviations which are not expected to affect the outcome
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- temperature slightly outside of recommended range. Sequential testing strategy preferred.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- temperature slightly outside of recommended range. Sequential testing strategy preferred.
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1-(N,N-bis(2-hydroxyethyl)amino)propan-2-ol
- EC Number:
- 229-764-5
- EC Name:
- 1-(N,N-bis(2-hydroxyethyl)amino)propan-2-ol
- Cas Number:
- 6712-98-7
- Molecular formula:
- C7H17NO3
- IUPAC Name:
- 1-[bis(2-hydroxyethyl)amino]propan-2-ol
- Test material form:
- other: Clear liquid
- Details on test material:
- - Name of test material (as cited in study report): Diethanolisopropanolamine (DEIPA)
- Substance type: Technical product
- Physical state: Liquid
- Analytical purity: 93%
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: No data
- Isomers composition: No data
- Purity test date: Not specified
- Lot/batch No.: 980035B
- Expiration date of the lot/batch: Not specified
- Stability under test conditions: Not specified
- Storage condition of test material: Not specified
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Covance Research Products, Inc (Kalamazoo)
- Age at study initiation: 8 weeks
- Weight at study initiation: 2.9-3 kg
- Housing: Not specified
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 +/- 3 [OECD guideline recommends 20 +/- 3, but unlikely to affect the outcome]
- Humidity (%): 40-60
- Air changes (per hr): 12-15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye served as a control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
VEHICLE
Not applicable - Duration of treatment / exposure:
- Eyes held closed for approximately 1 second after instillation
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3 [OECD guideline recommends a sequential testing strategy, in which an initial test is performed on one animal, using two additional animals if there are no severe irritant or corrosive effects exhibited. It is not clear from the test report if this sequential strategy was used, or if all three animals were treated concurrently]
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
Eyes were unwashed after treatment
SCORING SYSTEM: Scored for corneal opacity (0-4), conjuctival redness (0-3), chemosis (0-4), dischage (0-3) and iris reddening (0-2)
TOOL USED TO ASSESS SCORE: Binocular loupe and white halogen light
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- discharge
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- discharge
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: Reversibility not applicable since no effects seen
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- discharge
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: Reversibility not applicable since no effects seen
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Reversibility not applicable since no effects seen
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Reversibility not applicable since no effects seen
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Remarks:
- reddening
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- iris score
- Remarks:
- reddening
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: Reversibility not applicable since no effects seen
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Remarks:
- reddening
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: Reversibility not applicable since no effects seen
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Slight to moderate irritation was seen in the eyes of all three rabbits, which had fully reversed within 7 days.
All rabbits had moderate conjunctival redness, slight or moderate chemosis and moderate ocular discharge 1 hour after instillation. Twenty-four hours after instillation all rabbits had slight or moderate conjunctival redness and slight chemosis, in addition one rabbit exhibited moderate ocular discharge, corneal opacity and iris reddening. All rabbits had slight conjunctival redness at 48 and 72 hours after instillation. The test was terminated on day 8 due to the eyes of all rabbits having returned to normal. - Other effects:
- No signifcant effects on body weight
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In a GLP study, conducted according to OECD guideline 405, the instillation of undiluted DEIPA (0.1 ml) into the right eye of 3 rabbits was considered to cause slight to moderate transient eye irritation.
- Executive summary:
In a GLP study, conducted according to OECD guideline 405, an aliquot of 0.1 ml of undiluted DEIPA was instilled into the conjunctival sac of the right eye of three New Zealand White rabbits. The contralateral eye served as the untreated control. An ocular anaesthetic was used for 2 rabbits following discomfort observed in the second rabbit dosed. The eyes were examined for conjunctival redness, discharge, chemosis, corneal opacity and iris reddening at approximately 1, 24, 48 and 72 hours, and 7 days, post-instillation.
All rabbits had moderate conjunctival redness, slight or moderate chemosis and moderate ocular discharge 1 hour after instillation. Twenty-four hours after instillation all rabbits had slight or moderate conjunctival redness and slight chemosis, in addition one rabbit exhibited moderate ocular discharge, corneal opacity and iris reddening. All rabbits had slight conjunctival redness at 48 and 72 hours after instillation. The test was terminated on day 8 due to the eyes of all rabbits having returned to normal.
In this reliable study, the instillation of neat DEIPA was considered to cause slight to moderate transient eye irritation in rabbits.
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.
