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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
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- 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
Endpoint summary
Administrative data
Description of key information
skin irritation: not irritating (OECD TG 404; RL2, GLP); very slight erythema (grade 1) in 2/3 animals up to 48 h after patch removal, fully reversible within 72 h
eye irritation: not irritating (OECD TG 405; RL2, GLP); 2/3 animals showed ocular secretion after treatment; iris inflammation in 2/3 animals 1 h after application; conjunctival redness and chemosis up to day 2-5 after application
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:
- 1992-10-06 to 1992-10-09
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- May 12, 1981
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system 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
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: adjacent area of untreated skin served as negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 30-60 min after removal of the semi-occlusive dressing and 24, 48 and 72 h after patch removal
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: ca. 6 cm²
- Type of wrap if used: Ypsiplast ® (Holthaus Medical), held by non-irritating tape Elastoplast ® (Beiersdorf AG, Hamburg) and Stülpa ® (P. Hartmann AG, Heidenheim-Brenz)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual sample was carefully washed off with water or an appropriate solvent
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS
(indicate if minutes, hours or days) Day of exposure at 30-60 min after patch removal and 24, 48 and 72 h after patch removal
SCORING SYSTEM: according to OECD Test Guideline 404
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Very slight erythema (grade 1) was observed in 2/3 animals up to 48 h after patch removal, which were fully reversible within 72 h.
- Other effects:
- No other effects observed
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Polyglycerin caprinate was not irritating in thin in vivo skin irritation study in rabbit.
- Executive summary:
In a in vivo dermal irritation study according to OECD Test Guideline 404 (1981), three New Zealand White rabbits were dermally exposed to 0.5 mL of Polyglycerin caprinate (> 95% a.i.) for 4 h to 6 cm² skin area. Animals then were observed for 72 h. Irritation was scored by the method of OECD Test Guideline 404.
During the observation period only slight erythema (grade 1) in two of the three animals occurred, the observed effects were reversible within 72 h after application. In this study, Polyglycerin caprinate is not a dermal irritant.
Reference
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 |
Erythema Max. score: 4 |
Edema Max. score: 4 |
30 – 60 min |
1/0/1 |
0/0/0 |
24 h |
1/0/1 |
0/0/0 |
48 h |
1/0/1 |
0/0/0 |
72 h |
0/0/0 |
0/0/0 |
Average 24h, 48h, 72h |
0.67/0/0.67 |
0/0/0 |
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:
- 1992-10-08 to 1992-10-14
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- 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)
- 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
- 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
- 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
- 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.
Reference
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
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
In a in vivo dermal irritation study according to OECD Test Guideline 404 (1981), three New Zealand White rabbits were dermally exposed to 0.5 mL of Polyglycerin caprinate (> 95% a.i.) for 4 h to 6 cm² skin area. Animals then were observed for 72 h. Irritation was scored by the method of OECD Test Guideline 404.
During the observation period only slight erythema (grade 1) in two of the three animals occurred, the observed effects were reversible within 72 h after application. In this study, Polyglycerin caprinate is not a dermal irritant.
Eye irritation
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. In this study, Polyglycerin caprinate is not irritating to the eye.
Respiratory irritation
No data on the respiratory irritation of polyglycerin caprylate/caprinate are available.
There are no data gaps for the endpoint irritation/corrosion. No human information is available for this endpoint. However, there is no reason to believe that these results would not be applicable to humans.
Justification for classification or non-classification
Based on the available data polyglycerin caprylate/caprinate does not need to be classified for skin and eye irritation according to regulation (EC) 1272/2008.
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