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EC number: 402-370-2 | CAS number: 149057-70-5 AOC 1020X
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1987
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1981
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study available before entry into force of REACH
Test material
- Reference substance name:
- (ethyl-3-oxobutanoato-O'1,O'3)(2-dimethylaminoethanolato)(1-methoxypropan-2-olato)aluminium(III), dimerised
- EC Number:
- 402-370-2
- EC Name:
- (ethyl-3-oxobutanoato-O'1,O'3)(2-dimethylaminoethanolato)(1-methoxypropan-2-olato)aluminium(III), dimerised
- Cas Number:
- 149057-70-5
- Molecular formula:
- C14H28AlNO6
- IUPAC Name:
- octaaluminium(3+) octakis((2Z)-4-ethoxy-4-oxobut-2-en-2-olate) octakis(1-methoxypropan-2-olate) octakis(2-(dimethylamino)ethan-1-olate)
- Reference substance name:
- 1-methoxypropan-2-ol
- EC Number:
- 203-539-1
- EC Name:
- 1-methoxypropan-2-ol
- Cas Number:
- 107-98-2
- Molecular formula:
- C4H10O2
- IUPAC Name:
- 1-methoxypropan-2-ol
- Test material form:
- liquid
- Details on test material:
- purified with vacum distillation, analyzed by Gel permeation chromatography as stated in one of the study reports
Constituent 1
impurity 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- arachis oil
- Concentration / amount:
- 0.5%
- Day(s)/duration:
- 7 days
- Adequacy of induction:
- highest technically applicable concentration used
- Route:
- intradermal
- Vehicle:
- other:
- Remarks:
- Freund's Complete Adjuvant plus arachis oil B.P. at the ratio of 1:1
- Concentration / amount:
- 0.5%
- Day(s)/duration:
- 7 days
- Adequacy of induction:
- highest technically applicable concentration used
- Route:
- epicutaneous, open
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- Day(s)/duration:
- 7 days
- Adequacy of induction:
- highest technically applicable concentration used
Challenge
- No.:
- #20
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: petroletum jully B.P.
- Concentration / amount:
- 25% (challenge), 25% and 10% (re-challenge)
- Day(s)/duration:
- 1
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 20 test and 10 controls
- Details on study design:
- a) Induction of the test animals
Induction of the Test Animals: The hair was removed from an area approximately 40 mm x 60 mm on the shoulder region of each animal with veterinary clippers and a row of three injections (0.1 ml each) was made on each side of the mid-line. The injections were:
i) Freund's Complete Adjuvant plus arachis oil B.P. in the ratio 1:1.
ii) a 0,5% (w/v) dilution of test material in arachis oil B.P.
iii) a 0,5% (w/v) dilution of test material in a 1:1 preparation of Freund's Complete Adjuvant plus arachis oil B.P.
One week later, the same area on the shoulder region used previously for intradermal injections was clipped again and treated with a topical appli cation of the undiluted test material. The undiluted test material (0.2 - 0.3 ml) was applied on filter paper (WHATMAN No. 4: approximate size 40 mm x 20 rrm) which was held in place by a strip of surgical adhesive tape (BLENDERM: approximate size 60 mm x 25 mm) and covered with an overlapping length of aluminium foil. The patch and foil were further secured by a trip of elastic adhesive bandage (ELASTOPLAST: approximate size 250 rrm x 35 11111) wound in a double layer around the torso of each animal. This occlusive dressing was kept in place for 48 hours. Erythematous reactions were quantified immediately following removal of the patches, using the D - 3 scale in section b.
One week later, the same area on the shoulder region used previously for intradermal injections was clipped again and treated with a topical appli cation of the undiluted test material. The undiluted test material (0.2 -
0.3 ml) was applied on filter paper (WHATMAN No. 4: approximate size 40 mm x 20 rrm) which was held in place by a strip of surgical adhesive tape (BLENDERM: approximate size 60 mm x 25 mm) and covered with an overlapping length of aluminium foil. The patch and foil were further secured by a trip of elastic adhesive bandage (ELASTOPLAST: approximate size 250 rrm x 35 11111) wound in a double layer around the torso of each animal. This occlusive dressing was kept in place for 48 hours. Erythematous reactions were quantified immediately following removal of the patches, using the D - 3 scale in section b.
Induction of the Control Animals:
Intradermal injections were administered using an identical procedure to that used for the test animals, except that the injections were:
i) Freund's Complete Adjuvant plus arachis oil B.P. in the ratio 1:1.
ii) arachis oil B.P.
iii) Freund's Complete Adjuvant plus arachis oil B.P. in the ratio 1:1.
The topical applications followed the same procedure as for the test animals except that nothing was applied to the filter paper. Skin reactions were quantified as for the test animals.
b) Challenge
Two weeks after the topical inductions, an area, approximately 50 - 70 mm x 50 mm on both flanks of each animal, was clipped free of hair with veterinary clippers.
A quantity of D.1 - D.2 ml of the test material formulation (25% w/w in petroleum jelly B.P.) was applied to the shorn rfght flank of each animal on a 20 mm x 20 mm square of filter paper (WHATMAN No. 4) which was held in place by a strip of surgica1 adhesive tape (BLEND£RM: approximate size 60 mm x 50 mm). The vehic1e alone was similarly applied to the left shorn flank. The patches were occluded with an overlapping length of aluminium foil and secured by a strip of elastic adhesive bandage (ELASTOPLAST: approximate size 250 mm x 75 mm) wound in a double layer around the torso of each animal.
After 24 hours, the dressing was carefully cut using blunt-tipped scissors, removed and discarded. The position of the treatment site was identified by using a black indelible marker-pen. After a further 24 and 48 hours, any erythematous reactions were quantified using the four-point scale shown and the number of positive responses recorded
Scale:
0 - no reaction
1 - scattered mild redness
2 - moderate and diffuse redness
3 - intense redness and swelling
c) Re-challenge
All test and control animals were re-challenged seven days later using concentrations of 25% (w/w) and 10% (w/w) in petroleum jelly B.P. on previously untreated areas of the shorn flank as detailed in the original challenge. The skin reactions were estimated 24 and 48 hours after removal of the dressing s as for the challenge. To classify the sensitisation response, the percentage of test animals that showed a more severe reaction at the test material challenge site than the
most severe reaction seen in the control animals, was compared with the following scale:
% of animals sensitised Classification of sensitisation potential
0 Non-sensitiser
> 0 - 8 Weak sensitiser
> 8 - 28 Mild sensitiser
> 28 - 64 Moderate sensitiser
> 64 - 80 Strong sensitiser
> 80 - 100 Extreme sensitiser - Challenge controls:
- Induction of the Control Animals:
Intradermal injections were ad.ministered using an identical procedure to that used for the test animals, except that the injections were:
i) Freund's Complete Adjuvant plus arachis oil B.P. in the ratio 1:1.
ii) arachis oil B.P.
iii) Freund's Complete Adjuvant plus arachis oil B.P. in the ratio 1:1. The topical applications followed the same procedure as for the test animals except that nothing was applied to the filter paper. Skin reactions were quantified as for the test animals. - Positive control substance(s):
- yes
- Remarks:
- Formaldehyde (40% aqueous solution)
Results and discussion
- Positive control results:
- The strain used in these laboratories has been shown to produce a satisfactory sensitisation response using a known positive sensitiser
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: initial challenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25% in petrolatum jelly
- No. with + reactions:
- 13
- Total no. in group:
- 20
- Clinical observations:
- scale 0: 7 animals, scale 1: 11 animals, scale 2: 2 animals, scale 3: 0 animals
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other: initial challenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25% in petrolatum jelly
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Clinical observations:
- scale 0: 15 animals, scale 1: 4, scale 2: 1 scale 3: 0
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other: initial challenge
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 25%
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Clinical observations:
- scale 0: 2 animals, scale 1: 7 animals, scale 2: 1 animal
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- control - test material
- Reading:
- other: initial challenge
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 25%
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- scale 0: 8 animals, scale 1: 2 animals
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- freud's adjuvant and arachis oil
- Reading:
- other: initial challenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- vehicule
- Reading:
- other: iniitla challenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- vehicule
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 12
- Total no. in group:
- 20
- Clinical observations:
- scale 0:8, scale 1: 12
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Clinical observations:
- scale 0: 18, scale 1: 2
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Clinical observations:
- scale 0:7 animals, scale 1:3 animals
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
Skin response scale:
0 - no reaction
1- scattered mild redness
2- moderate and diffuse redness
3- intense redness and swelling
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material, therefore, produced a 0% (0/20) sensitisation rate and therefore was classified as a NON-SENSITIZER to guinea pig skin.
- Executive summary:
In a guinea pigs OECD 426 test, the test material tested at 10% and 25% in challenge phase produced a 0% (0/20) sensitisation rate and therefore was classified as a NON-SENSITIZER to guinea pig skin.
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