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EC number: - | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 05 February 2013 to 26 February 2013
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with GLP and agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.
- Justification for type of information:
- See Read-Across Justification in Section 13.
Cross-reference
- Reason / purpose for cross-reference:
- other: Target record
Reference
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted on read across material
- Justification for type of information:
- See Read-Across Justification in Section 13.
- Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #1
- Time point:
- other: Mean of 24, 48 and 72 hour observations
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- Discharge
- Basis:
- animal #1
- Time point:
- other: Mean of 24, 48 and 72 hour observations
- Score:
- 2.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: Mean of 24, 48 and 72 hour observations
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: Not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: Mean of 24, 48 and 72 hour observations
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: Mean of 24, 48 and 72 hour observations
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: Mean of 24, 48 and 72 hour observations
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: Mean of 24, 48 and 72 hour observations
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #2
- Time point:
- other: Mean of 24, 48 and 72 hour observations
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- Discharge
- Basis:
- animal #2
- Time point:
- other: Mean of 24, 48 and 72 hour observations
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: Mean of 24, 48 and 72 hour observations
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: Not applicable
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reaction mass of sodium hydrogen N-(1-oxooctadecyl) -L-glutamate and sodium hydrogen n-(1-oxohexadecyl) -L-glutamate
- IUPAC Name:
- Reaction mass of sodium hydrogen N-(1-oxooctadecyl) -L-glutamate and sodium hydrogen n-(1-oxohexadecyl) -L-glutamate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Appearance: White to pale yellow powder
- Storage conditions of test material: Room temperature (15-25 °C)
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: approximately 14 weeks
- Weight at study initiation: 3491 and 3551 g
- Housing: Individually housed in AAALAC approved metal wire rabbit cages. Cages were of an open wire structure and cages were placed together to allow some social interaction with rabbits in adjoining cages
- Diet: ad libitum
- Water: municipal tap water ad libitum
- Acclimation period: 27 days
ENVIRONMENTAL CONDITIONS
- Temperature: 16.8 to 20.2 °C
- Humidity: 24 to 68 % (relative)
- Air changes: 15 to 20 changes per hour
- Photoperiod: 12 hour light/dark cycle (light from 06:00 to 18:00)
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The untreated contralateral eye served as the control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
- pH: The pH of the test material was determined prior to dosing. The test material was found to be acceptable for use in the test (pH 5)
- TOPICAL ANAESTHETIC AND SYSTEMIC ANALGESIC
- Schedule: Sixty minutes (60 ± 10 minutes) prior to administration, a systemic opiate analgesic (Buprenorphine 0.01 mg/kg) was administered by subcutaneous injection. Five minutes (5 ± 1.5 minutes) prior to administration, a topical ocular anaesthetic (Humacain (oxybuprocaine) one-two drops per eye) was applied to each eye (including the control eye to ensure direct comparison of any ocular observations). Eight hours (8 to 9 hours) after test material application, Buprenorphine 0.01 mg/kg and a nonsteroidal anti-inflammatory drug (NSAID) (Meloxicam 0.5 mg/kg) were administered by subcutaneous injection. The systemic opiate analgesic was injected approximately every 12 hours and the NSAID every approximately every 24 hours until the ocular lesions were resolved and no clinical signs of pain or distress were present. - Duration of treatment / exposure:
- A single dose was administered
- Observation period (in vivo):
- 3 weeks (21 days)
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): physiological saline
- Time after start of exposure: At the 1 and 24 hour observation point in one animal and at the 1 hour observation point only in the second animal.
SCORING SYSTEM: Draize (1977) and OECD 405.
The eyes were examined at in the first animal 1, 24, 48 and 72 hours, then 1, 2 and 3 weeks after treatment. The eyes were examined in the second animal 1, 24, 48 and 72 hours, then 1 and 2 weeks after treatment. The duration of the observation period was sufficient to identify reversibility or irreversibility of changes.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- 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: 21 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- discharge
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- discharge
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- For the irritant response of each animal, the mean score of the 24, 48 and 72 hour observations were calculated for each effect observed.
- Other effects:
- There was no mortality during the test. One animal showed slight bodyweight loss during the treatment period. The second rabbit was found to be within the normal range. There were no clinical signs observed that could be related to treatment.
No initial pain reaction was observed in either animal.
Any other information on results incl. tables
Table 1: Results for Animal No. 01973
Time |
Irritation Score |
IPR/ PR |
||||||
Conjunctivae |
Cornea |
Iris |
Control eye |
|||||
R |
CH |
D |
OD |
OE |
||||
0 hours* |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 hour |
2 |
2 |
3 |
0 |
0 |
0 |
0 |
0 |
24 hours |
2 |
2 |
3 |
1 |
3 |
0 |
0 |
0 |
48 hours |
1 |
1 |
3 |
1 |
3 |
0 |
0 |
0 |
72 hours |
1 |
1 |
2 |
1 |
3 |
0 |
0 |
0 |
7 days |
1 |
1 |
1 |
1 |
3 |
0 |
0 |
0 |
14 days |
1 |
1 |
1 |
1 |
3 |
0 |
0 |
0 |
21 days |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
* Pre-treatment
IPR/PR - Initial Pain Reaction/Pain Response
R – Redness
CH- Chemosis
D – Discharge
OD –Opacity (degree of density)
OE – Area of opacity
Table 2: Results for Animal No. 01950
Time |
Irritation Score |
IPR/PR |
||||||
Conjunctivae |
Cornea |
Iris |
Control eye |
|||||
R |
CH |
D |
OD |
OE |
||||
0 hours* |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 hour |
2 |
2 |
3 |
1 |
4 |
0 |
0 |
0 |
24 hours |
2 |
1 |
2 |
1 |
4 |
0 |
0 |
0 |
48 hours |
2 |
1 |
1 |
1 |
3 |
0 |
0 |
0 |
72 hours |
2 |
1 |
1 |
1 |
3 |
0 |
0 |
0 |
7 days |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
14 days |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
* Pre-treatment
IPR/PR - Initial Pain Reaction/Pain Response
R – Redness
CH- Chemosis
D – Discharge
OD –Opacity (degree of density)
OE – Area of opacity
Table 3: Results of Bodyweight Observations
Time point |
Bodyweight (g) |
Bodyweight gain (g) |
Animal no. 01973 |
||
Prior to treatment |
3491 |
325 |
21 February 2013 (16 days) |
3752 |
|
Termination of the study |
3816 |
|
Animal no. 01950 |
||
Before treatment |
3551 |
-1 |
Before euthanasia |
3550 |
Applicant's summary and conclusion
- Interpretation of results:
- Category II
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the study, the test material caused eye irritation in two New Zealand White rabbits. The effects were found to be reversible within 21 days.
- Executive summary:
The eye irritation potential of the test material was investigated in New Zealand White rabbits in a study conducted in accordance with the standardised guideline OECD 405 under GLP conditions.
Two animals were exposed to the test material. 0.1 g of the test material was instilled into the conjunctival sac of the eye of each rabbit. The eyes were rinsed at the 1 and 24 hour examination points with physiological saline in one animal, and at the 1 hour observation point only in the second animal. Prior to dosing and during the observation period, a pain management regimen was administered (topical anaesthetic and systemic analgesic) which was continued until all eye effects had resolved. The animals were observed for up to 21 days, and any effects noted were evaluated in accordance with the Draize Scale (1977).
The animal individual mean scores (considering readings taken at 24, 48 and 72 hours after the treatment) were as follows:
Chemosis: 1.33 and 1.00
Discharge: 2.67 and 1.33
Redness: 1.33 and 2.00
Corneal opacity: 1.00 and 1.00
Iris: 0.00 and 0.00
There were no observed pain reactions related to the test material. One animal was reported to have a reduced bodyweight during the study.
Under the conditions of the study, the test material caused eye irritation in two New Zealand White rabbits. The effects were found to be reversible within 21 days.
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