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EC number: 946-420-6 | 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:
- 1992-10-08 to 1992-10-14
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- February 24, 1987
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reaction products of decanoic acid and lauric acid with glycerol and polyglycerol
- EC Number:
- 946-420-6
- Molecular formula:
- not applicable
- IUPAC Name:
- Reaction products of decanoic acid and lauric acid with glycerol and polyglycerol
- Test material form:
- liquid: viscous
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Housing: individual housing (50 x 45 x 40 cm, L x B x H) in a battery of cages, each equipped with a paper roll disposal system
- Diet (e.g. ad libitum): ad libitum, Ssniff K-Haltung (Zuchtdiät für Kaninchen), Form: pellets, 1.0-1.5 cm long, 0.5 cm diameter, Ssniff Spezialdiäten GmbH, 4770 Soest/Westfalen
- Water (e.g. ad libitum): ad libitum, drinking water as for human consumption, System: drinking nipples
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12h light/ 12h dark cycles
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: contralateral untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Duration of treatment / exposure:
- the eye were not washed after treatment
- Observation period (in vivo):
- 24, 48 and 72 h after treatment and thereafter once daily up to days 5-6 post application
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): not washed
SCORING SYSTEM: According to OECD Test Guideline 405
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Irritant / corrosive response data:
- 2/3 animals showed ocular secretion after treatment. Iris inflammation was observed in 2/3 animals 1 h after application of the test item. In all animals, conjunctival redness and chemosis were observed up to day 2-5 after application of the test item.
- Other effects:
- no other effects observed
Any other information on results incl. tables
Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test
Score at time point / Reversibility |
Cornea Max. score: 4
|
Iris Max. score: 2
|
Conjunctivae Max. score: 3
|
Chemosis Max. score: 4
|
60 min |
0/0/0 |
1/1/0 |
1/1/2 |
2/1/1 |
24 h |
0/0/0 |
0/0/0 |
2/1/2 |
2/1/1 |
48 h |
0/0/0 |
0/0/0 |
2/1/2 |
2/1/1 |
72 h |
0/0/0 |
0/0/0 |
1/0/1 |
1/0/1 |
Average 24h, 48h, 72h |
0/0/0
|
0/0/0
|
1.67/0.67/1.67
|
1.67/0.67/1
|
Reversibility*) |
c |
c |
c |
c |
4 d |
0/0/0 |
0/0/0 |
1/0/1 |
0/0/0 |
5 d |
0/0/0 |
0/0/0 |
1/0/0 |
100/0 |
6 d |
0/#/# |
0/#/# |
0/#/# |
0/#/# |
# In animals 2 and 3 the test was terminated after examination on day 5
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study, Polyglycerin caprinate was not irritating to the eye.
- Executive summary:
In a primary eye irritation study according to OECD guideline 405 (February 24, 1987) 0.1 mL of polyglycerin caprinate (>95% a.i.) was instilled into the conjunctival sac of the left eye of 3 New Zealand White rabbits, the untreated right eye of each animal served as control. The were not rinsed after treatment. The animals were observed for clinical signs of eye irritation and inflammation at 1 h after instillation and after 24, 48 and 72h, thereafter the animals were examined once daily up to day 5 -6. Two animals (no. 1 and 3) showed ocular secretion after treatment. Iris inflammation was observed in animal no. 1 and 2, 1 h p.a. In all animals signs of redness and chemosis of the conjunctivae were observed up to 2-5 days p.a. All detected effects were reversible within 6 days p.a. Thus, the test item is considered to be not irritating to the eye according to GHS criteria.
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