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EC number: 208-634-1 | CAS number: 536-45-8
- 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
Endpoint summary
Administrative data
Description of key information
skin irritation (no guideline followed): not irritating
eye irritation (no guideline followed): not irritating
Read-across from p-anisic acid (CAS 100-09-4)
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Refer to analogue justification provided in IUCLID section 13.
- Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of 2 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- other: source: CAS 100-09-4, Thyssen, 1979, rabbit
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 2 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- other: source: CAS 100-09-4, Thyssen, 1979, rabbit
- Irritation parameter:
- other: eschar formation
- Basis:
- mean
- Remarks:
- of 2 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- other: source: CAS 100-09-4, Thyssen, 1979, rabbit
- Irritant / corrosive response data:
- At none of the reading time points, reactions indicative of skin irritation were noticed.
- Other effects:
- - Adverse systemic effects: no systemic effects were reported.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The read across approach is justified in the analogue justification. The target and source substances are considered unlikely to differ in their skin irritation potential. No in vivo skin irritation potential was found in a rabbit study for the source substance. Therefore, no skin irritation potential is expected for target substance sodium anisate.
Reference
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:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Refer to analogue justification provided in IUCLID section 13.
- Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 2 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- other: source: CAS 100-09-4, Thyssen, 1979, rabbit
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of 2 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- other: source: CAS 100-09-4, Thyssen, 1979, rabbit
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of 2 animals
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Reversibility:
- not fully reversible within: 48 h
- Remarks on result:
- other: source: CAS 100-09-4, Thyssen, 1979, rabbit
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of 2 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- other: source: CAS 100-09-4, Thyssen, 1979, rabbit
- Irritant / corrosive response data:
- A grade 1 conjunctivae redness was noted 1 h after instillation in both animals. At the 24 h reading time point, the conjunctivae redness graded 1 was still present in one animal, whereas in the second, the finding seems to become weaker, as based on the grading reported as (1). After 48 hours, no more conjunctivae redness was seen for both animals, indicating complete reversibility. No further effects were noticed.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The read across approach is justified in the analogue justification. The target and source substances are considered unlikely to differ in their eye irritation potential. No in vivo eye irritation potential was found in an vivo rabbit study with the analogue source substance p-anisic acid (CAS 100-09-4). Therefore, no eye irritation potential is expected for target substance sodium anisate.
Reference
Table 1: In Vivo Eye Irritation Scores
Animal No. |
Irritation parameter |
Reading times |
|||||
|
|
1h |
24 h |
48 h |
72 h |
96 h |
7 days |
21 |
cornea |
0 |
0 |
0 |
0 |
0 |
0 |
|
iris |
0 |
0 |
0 |
0 |
0 |
0 |
|
conjunctiva |
1 |
1 |
0 |
0 |
0 |
0 |
|
chemosis |
0 |
0 |
0 |
0 |
0 |
0 |
|
lacrimation |
0 |
0 |
0 |
0 |
0 |
0 |
22 |
cornea |
0 |
0 |
0 |
0 |
0 |
0 |
|
iris |
0 |
0 |
0 |
0 |
0 |
0 |
|
conjunctiva |
1 |
(1) |
0 |
0 |
0 |
0 |
|
chemosis |
1 |
0 |
0 |
0 |
0 |
0 |
|
lacrimation |
0 |
0 |
0 |
0 |
0 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for read-across
There are no experimental data available regarding the skin and eye irritation/corrosion potential of sodium anisate (CAS 536-45-8). Thus, read-across from an appropriate surrogate substance (p-anisic acid, CAS 100-09-4) is conducted in accordance with Regulation (EC) No 1907/2006, Annex XI, 1.5 in order to fulfil the standard information requirements defined in Regulation (EC) No 1907/2006, Annex VII and VIII, 8.1. Common functional groups and structural similarities of the source and target substance are the basis of read-across. A detailed justification for the analogue read-across approach is provided in the technical dossier (see IUCLID Section 13).
Skin
The skin irritation potential of p-anisic acid (CAS 100-09-4) was determined in a primary skin irritation/corrosion study in the rabbit. In this study 500 mg test substance moistened with water were applied to the inner auricle surface of 2 New Zealand White rabbits under semi-occlusive conditions for 24 h (Thyssen, 1979). Scoring of skin reactions (erythema, edema and eschar formation) was performed immediately, 24, 48 and 72 hours as well as 7 days after removal of the patch. Exposure to the test substance did not result in any signs of irritation at any reading point. The overall mean irritation scores over 24, 48 and 72 h for erythema and edema were 0. No mortality occurred. Based on the results, the test item was not irritating to the skin in the in vivo primary skin/corrosion study in rabbits under the experimental conditions used.
Based on the available data on the surrogate substance p-anisic acid (CAS 100-09-4), sodium anisate is not considered to exhibit irritating properties to the skin.
Eye
The eye irritation potential of p-anisic acid (CAS 100-09-4) was determined in three studies. An acute eye irritation study in the rabbit, a bovine corneal opacity and permeability test (BCOP test) and a HET-CAM study were conducted.
In an acute eye irritation study samples of 50 mg p-anisic acid (moistened with water) were instilled into one eye of each of 2 New Zealand White rabbits (Thyssen, 1979). Eye reactions were scored 1, 24, 48, 72 and 96 hours as well as 7 days after instillation. Instillation of the test substance resulted in effects on the conjunctivae. The irritation of the conjunctivae consisted of grade 1 redness noted at 1 and 24 hours and completely resolved within 48 hours in both animals. A grade 1 chemosis was noted in 1 animal 1 h after instillation and was fully reversible within 24 hours. The overall mean irritation scores over 24, 48 and 72 h for conjunctival redness, chemosis, iris and corneal effects were 0.33, 0, 0 and 0, respectively. No mortality occurred. Based on the results, the test substance was not irritating to the eyes under the conditions of the test.
A supporting BCOP test with p-anisic acid (CAS 100-09-4) is available and was performed according to OECD Guideline 437 and in compliance with GLP (Paulus, 2009). The non-surfactant solid test substance was applied as a solid to the epithelial surface of three cattle corneas for 4 hours at 32 °C. The applied amounts were ranging from 203 to 294 mg. After exposure the corneas were washed and the damage by the test substance was assessed directly by quantitative measurement of changes in corneal opacity with an opacitometer. In addition the permeability of the corneas was measured with an ultraviolet/visible spectrophotometer after incubation of the corneas with sodium fluorescein solution for 90 min. The results of the opacity and permeability measurement were used to calculate an in vitro irritation score (IVIS) of 3.274. The negative control responses for opacity and permeability were less than the upper limits of the laboratory historical range indicating that the negative control (physiol. saline) did not induce irritancy on the corneas. The mean in vitro irritation score of the positive control (20% (w/v) imidazole) was 62.4670 and within the historical positive control data range. It was therefore concluded that the test conditions were adequate and that the test system functioned properly. Since p-anisic acid induced an IVIS of > 3 ≤ 55, no prediction on the classification could be made based on this test, except for the prediction that the test substance is not expected to cause severe damage to the eye.
In a supporting HET CAM study that was performed according to the ICCVAM recommended test method protocol, dated November 2006 and in compliance with GLP (Paulus, 2010) the irritation potential of p-anisic acid (CAS 100-09-4) was assessed by detection of damages in blood vessels under the chorioallantoic membrane (CAM) of nine day incubated chicken eggs. Nine day incubated chicken eggs were opened on the air bubble with a rotating dentist's saw blade. The inner membrane was moistened with 0.9% NaCl and the egg was placed in an incubator for 30 min. After this incubation the solution was decanted and the inner membrane was carefully removed with forceps. The test item (approximately 110 mg) was directly applied to the CAM surface so that 50% of the membrane were covered. The following parameters were observed: haemorrhage from the vessels, vascular lysis, coagulation (intra- and extravascular protein denaturation). The reactions of the CAM were observed over a period of 300 sec. The time for the appearance of each endpoint was monitored and recorded in seconds and a resulting irritation score (IS) was calculated. Physiological saline served as the negative control while 0.1 N sodium hydroxide (NaOH) and 1% sodium dodecyl sulphate (SDS) served as positive controls. Five replicates were used for the test item and three each for the positive and negative controls.
Application of the test item did not result in damage to the vessels of the CAM and the resulting IS was 0.0. Also the negative control induced no irritating effect (mean IS = 0.0), while both positive controls induced severe damage to the CAM blood vessels (mean IS for NaOH and SDS was 20.5 and 11.32, respectively). Thus, the results of this study gave no indication of a damaging effect of the test item to be expected for the eye.
Based on the available data on the surrogate substance p-anisic acid (CAS 100-09-4), sodium anisate is not considered to exhibit irritating properties to the eyes.
The target and source substances are considered unlikely to differ in their skin and eye irritation potential. Based on the available data on the source substance p-anisic acid (CAS 100-09-4), sodium anisate is not considered to exhibit irritating properties to the eye.
Justification for classification or non-classification
Based on read-across, the available data on skin and eye irritation do not meet the criteria for classification according to Regulation (EC) No. 1272/2008 and are therefore conclusive but not sufficient for classification.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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