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EC number: 946-958-1 | 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 13 August 1979 to 26 September 1979
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Older study conducted prior to development of GLP and current test guideline; methodology is not comparable to current guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The study was conducted prior to adoption of OECD test guidelines. A single semi-occluded 4-hour topical application was made to the dorsum of eight rabbits; the reactions were assessed at 24, 48 and 72 hours post application. Whilst the application method is similar to current guidelines, a non-standard scoring system was used and observations were not made beyond 72 hours, therefore this study is not considered to be comparable to current guidelines.
- GLP compliance:
- no
- Remarks:
- Conducted prior to development of GLP
Test material
- Reference substance name:
- Reaction products of 7-hydroxy-3,7-dimethyloctanal and methyl 2-aminobenzoate
- IUPAC Name:
- Reaction products of 7-hydroxy-3,7-dimethyloctanal and methyl 2-aminobenzoate
- Reference substance name:
- Aurantoin
- IUPAC Name:
- Aurantoin
- Test material form:
- liquid: viscous
- Details on test material:
- - Name of test material (as cited in study report): Aurantoin, use described as perfumery material
- Physical state: Clear, yellow viscous liquid
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 9-12 weeks
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- 0.5 mL of undiluted test substance was applied to the clipped dorsum of each rabbit.
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- Observations were made immediately after removal of the patch, and 24, 48 and 72 hours after application.
- Number of animals:
- Eight rabbits (one test substance and three reference controls applied to randomised sites on the rabbits).
- Details on study design:
- TEST SITE:
- Area of exposure: 2.5 x 2.5 cm patch on dorsum
- Type of wrap if used: The patches were prepared by attaching a piece of thin flexible polythene (3 cm x 3 cm) to a piece of zinc oxide plaster (9 cm x 2.5 cm). A 2.5 cm square of cotton gauze (8-ply folded in two) was placed onto the polythene so that the edges of the pad were attached to the plaster. The test substance was applied directly to the dry patch. The patches were firmly attached and the animals immobilised during exposure.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treatment sites were wiped clean of excess test substance at patch removal
- Time after start of exposure: 4 hours
SCORING SYSTEM: An eight point anchored ordinate scale was used (see below). The test sites were scored for erythema, oedema, cracking, scaling, scabbing, presence of exudate and haemorrhage.
a = marginal/very slight; 1 point
b = slight; 2 points
c = fairly distinct; 3 points
d = quite distinct; 4 points
e = becoming well developed; 6 points
f = well developed; 8 points
g = becoming severe; 10 points
h = severe; 12 points
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 31
- Max. score:
- 288
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 25
- Max. score:
- 288
- Reversibility:
- not specified
- Irritant / corrosive response data:
- Marginal/slight erythema was observed in 3 animals at patch removal; 3 animals exhibited slight erythema whilst 2 animals exhibited fairly distinct erythema. Four animals exhibited marginal/very slight oedema at this time point, with 3 animals exhibiting slight oedema and the 1 remaining animal exhibiting fairly distinct oedema.
The test site of 1 rabbit had returned to normal 24 hours after application. Six rabbits exhibited marginal/very slight to slight erythema and oedema at 24 hours, the remaining rabbit exhibited erythema that was 'becoming well developed' and quite distinct erythema.
By the 48 hour observation, a second rabbit was no longer displaying signs of irritation. Five rabbits were displaying marginal/very slight erythema, and no reaction to marginal/very slight oedema. One of these rabbits also displayed marginal/very slight cracking of the skin. The remaining rabbit exhibited quite distinct erythema and 'becoming well developed' oedema.
At the 72 hour observation, 5 rabbits were free of erythema and oedema however 3 of these rabbits exhibited marginal/very slight cracking of the skin. Two rabbits still exhibited marginal/very slight erythema and oedema, with one rabbit exhibiting quite distinct erythema and oedema. - Other effects:
- Pale yellow discolouration was observed in 5 animals at patch removal. The irritant response produced by the test substance, aurantiol pure, was greater than that produced by diethyl phthalate, but less than that produced by cyclamen aldehyde and geraniol.
Any other information on results incl. tables
Table 1: Skin irritation results
Rabbit No. |
Time after application |
|||||||||||
4 hours (patch removal) |
24 hours |
48 hours |
72 hours |
|||||||||
E |
O |
C |
E |
O |
C |
E |
O |
C |
E |
O |
C |
|
1 |
b* |
a |
- |
a |
- |
- |
- |
- |
- |
- |
- |
a |
2 |
b* |
b |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
3 |
c* |
c |
- |
b |
b |
- |
a |
- |
- |
- |
- |
- |
4 |
a* |
b |
- |
a |
a |
- |
a |
a |
- |
- |
- |
a |
5 |
c* |
b |
- |
e |
d |
- |
d |
e |
- |
d |
d |
a |
6 |
a |
a |
- |
b |
b |
- |
a |
a |
- |
a |
- |
- |
7 |
a |
a |
- |
b |
a |
- |
a |
- |
a |
- |
- |
a |
8 |
b |
a |
- |
b |
a |
- |
a |
a |
- |
a |
a |
- |
E = erythema; O = oedema; C = cracking.
* = pale yellow discolouration of test site; - = no reaction observed
Scoring System:
a = marginal/very slight = 1
b = slight = 2
c = fairly distinct = 3
d = quite distinct = 4
e = becoming well developed = 6
f = well developed = 8
g = becoming severe = 10
h = severe = 12
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Aurantoin caused slight irritation in rabbits following a 4-hour semi-occlusive exposure but insufficient for classification.
- Executive summary:
The skin irritation potential of aurantiol pure was evaluated in New Zealand White rabbits. The study design and scoring method are not comparable to current OECD test guidelines. The test substance was applied to the clipped dorsal skin of 8 rabbits, and held in place under a semi-occlusive dressing for four hours. Each rabbit also received applications of 3 reference substances, simultaneously (diethyl phthalate, cyclamen aldehyde and geraniol). After the exposure period, the patches were removed and residual test substance was removed by wiping. Skin reactions were scored immediately after patch removal, then at 24, 48 and 72 hours after application. Reactions (erythema, oedema, cracking, scaling, scabbing, exudant and haemorrhage) were graded according to an 8-point anchored ordinate scale, ranging from ‘very slight’ to ‘severe’. The test substance caused marginal/slight to slight erythema in 7 rabbits, with 1 rabbit exhibiting quite distinct to becoming well developed erythema and oedema. Cracking of the skin of the test site was observed in 1 rabbit at the 48 hour observation, and in 4 rabbits at the 72 hour observation. With the exception of 1 rabbit, reactions appeared to ameliorate between the 24 and 72 hour observations. Erythema and oedema persisted in 3 rabbits at the 72 hour time point; as no further observations took place it is not possible to conclude on reversibility of reactions. The irritant response produced by the test substance, aurantiol pure, was greater than that produced by diethyl phthalate, but less than that produced by cyclamen aldehyde and geraniol. It can be concluded that the test substance was slightly irritating to rabbit skin.
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