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EC number: 204-263-4 | CAS number: 118-60-5
- 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
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Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- January 23 to February 16, 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: guideline test with GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Sensitization endpoint information was published in 1990, when GMPT test was still state of the art. To avoid additional animal testing LLNA was not performed.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- Forty female SPF albino guinea pigs of the Dunkin Hartley strain were obtained from the Møllegaard Breeding Centre ApS, Ejby, DK-4623 Lille Skensved. At start of the experiment the guinea pigs were 6 to 7 weeks old and weighed between 291 and 381 g.
The guinea pigs were housed in opaque PPL (Type IV) cages, two or three to a cage. The bedding used was pinewood sawdust "Spanvall Special White" from Spanvall A/S, Jorløse, DK-4490 Jerslev. The guinea pigs had free access to a pelleted diet, "3113 Altromin", from Chr. Petersen A/S, DK-4100 Ringsted, and vitamin C enriched tap water. Regular analyses for relevant possible water contaminants are performed. The room temperature was set at 21 ±2 °C and the relative humidity at 55 ±15%, Air change 6 times an hour and light on from 6 to 18 h. Analysis certificate of bedding is presented. Declaration and analysis of diet mixture are given in Appendices. - Route:
- intradermal and epicutaneous
- Vehicle:
- other: groundnut oil for intradermal induction, Ethanol 96% : diethyl phthalate (DEP) 1:1 for dermal induction and challenge
- Concentration / amount:
- On the basis of the preliminary investigations, the following dose levels were selected: A concentration of 2.5% (w/w) was selected for the intradermal induction. A 50% (w/w) test concentration was chosen for the dermal induction and for the challenge application a 25% (w/w) test concentration was selected.
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: groundnut oil for intradermal induction, Ethanol 96% : diethyl phthalate (DEP) 1:1 for dermal induction and challenge
- Concentration / amount:
- On the basis of the preliminary investigations, the following dose levels were selected: A concentration of 2.5% (w/w) was selected for the intradermal induction. A 50% (w/w) test concentration was chosen for the dermal induction and for the challenge application a 25% (w/w) test concentration was selected.
- No. of animals per dose:
- 20
- Details on study design:
- Groups and numbers
The guinea pigs were randomly allocated into two groups and earmarked with a punched number. To secure that each animal could easily be identified the guinea pig with the highest number in a cage was marked on the forehead with a red India ink pen and the guinea pig with the second highest number was marked green.
The groups and numbers were as follows:
Control group: 20
test group: 20
PRELIMINARY INVESTIGATIONS
The intradermal irritancy of the test article was investigated in order to find a slight to moderate irritant test concentration for the intradermal induction. The topical irritancy of the test article was investigated in order to find a slight to moderate irritant concentration for the dermal induction.The topical irritancy of the test article was investigated in order to find the highest non-irritant concentration for the challenge application.
The procedure was in two parts: induction and challenge
Induction test group:
intradermal injection: An area of dorsal skin 4 x 6 cm in the scapular region was clipped free of hair with an electric clipper. Three pairs of intradermal injections were given simultaneously into this area. Each dose was 0.05 ml. The vehicle was groundnut oil. Preparations for injection were as follows:
1. Freund's complete adjuvant diluted 1:1 with water for injection.
2. 2.5% (w/w) test article.
3. 5.0% (w/w) test article and Freund’s complete adjuvant in the ratio 1:1.
Topical Application
Six days after the injections, the same 4 x 6 cm scapular area was clipped free of hair. To provoke a mild inflammatory reaction 10% sodium lauryl sulphate in petrolatum was massaged into the skin with a glass rod. 24 hours later 0,4 ml of 50% (w/w) test article in ethanol 96%/DEP (1:1) was spread over a 3 x 5 cm patch of Whatman No. 3 MM paper. The patch was placed on the skin and covered with 7 cm impermeable adhesive tape (Blendenn 5 cm width). This was firmly secured with an adhesive bandage (Scanpor Tape 5 cm width) wound round the trunk. The dressing was left in place for 48 hours.
Induction control group
intradermal injection:
An area of dorsal skin 4 x 6 cm in the scapular region was clipped free of hair with an electric clipper. Three pairs of intradermal injections were given simultaneously into this area. Each dose was 0.05 ml. The vehicle was groundnut oil, Ph. Nord. Preparation for injections were as follows:
1. Freund's complete adjuvant diluted 1:1 with water for injection.
2. vehicle.
3. vehicle and Freund’s complete adjuvant in the ratio 1:1.
Topical Application:
Six days after the injections, the same 4 x 6 cm scapular area was clipped free of hair. To provoke a mild inflammatory reaction 10% sodium lauryl sulphate in petrolatum was massaged into the skin with a glass rod* 24 hours later 0,4 ml ethanol 96%/DEP (1:1) was spread over a 3 x 5 cm patch of Whatman No. 3 MM paper. The patch was placed on the skin and covered with 7 cm impermeable adhesive tape (Blenderm 5 cm width). This was firmly secured with an adhesive bandage (Scanpor Tape 5 cm width) wound round the trunk. The dressing was left in place for 48 hours.
challenge:
The guinea pigs were challenged topically three weeks after the intradermal induction. The vehicle was ethanol 96% and diethyl phthalate (DEP) in the ratio 1:1 (w/w).
Hair was removed with an electric clipper from a 5 x 5 cm area from both flanks of the guinea pigs in the test group and the control group. About 0.1 ml of 25% (w/w) test article was applied to a 2 x 2cm Whatman No. 3 MM paper and placed on the left flank of the guinea pigs in the test group and on the right flank of the guinea pigs in the control group. In a similar way 0.1 ml vehicle was applied on the right flank of the guinea pigs in the test group. The patches were covered with 4 cm Blenderm (5 cm width) and secured with Scanpor Tape (7.5 cm width) wound round the trunk. After 24 hours of exposure the patches and tape were removed.
Reading Challenge Reactions
Each challenge site was read 24, 48 and 72 hours after removal of the patch. At least three hours before the 24-hour reading the sites were clipped and shaved facilitating the evaluation. - Positive control substance(s):
- not specified
- Positive control results:
- no data
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%(w/w) test article
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- 6/20 animals showed grade 1 reaction on the vehicle site, one of these also a grade 1 reaction on the test site.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25%(w/w) test article. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: 6/20 animals showed grade 1 reaction on the vehicle site, one of these also a grade 1 reaction on the test site..
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: vehicle control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- 5/20 animals showed grade 1 reaction to the vehicle
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: vehicle control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: 5/20 animals showed grade 1 reaction to the vehicle.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%(w/w) test article
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- 2/20 animals showed grade 1 reaction on the vehicle site, one of these also a grade 1 reaction on the test site.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%(w/w) test article. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: 2/20 animals showed grade 1 reaction on the vehicle site, one of these also a grade 1 reaction on the test site..
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: vehicle control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- 1/20 animals showed grade 1 reaction to the vehicle
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: vehicle control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: 1/20 animals showed grade 1 reaction to the vehicle.
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 25%(w/w) test article
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no positive reaction was observed
- Remarks on result:
- other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 25%(w/w) test article. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no positive reaction was observed.
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- other: vehicle control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 29
- Clinical observations:
- no positive reaction was observed
- Remarks on result:
- other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: other: vehicle control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 29.0. Clinical observations: no positive reaction was observed.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the experimental conditions described in the authorized report the test article did not produce any evidence of delayed contact hypersensitivity in guinea pigs.
- Executive summary:
This study was conducted to investigate the allergenic potential of test article according to OECD guideline No. 406. The procedure was in two parts: induction and challenge. On the basis of the preliminary investigations, the following dose levels were selected: A concentration of 2.5% (w/w) was selected for the intradermal induction. A 50% (w/w) test concentration was chosen for the dermal induction and for the challenge application a 25% (w/w) test concentration was selected. The guinea pigs were challenged topically three weeks after the intradermal induction. Each challenge site was read 24, 48 and 72 hours after removal of the patch. At least three hours before the 24-hour reading the sites were clipped and shaved facilitating the evaluation. No skin responses evaluated as positive were observed.
In test and control groups sporadic grade 1 reactions to the vehicle were observed.
The guinea pigs made normal body weight changes over the duration of the study and exhibited normal appearance and behaviour.
Therefore, under the experimental condition, test article failed to cause allergenic response to guinea pigs.
Reference
Health and body weight
The guinea pigs made normal body weight changes over the duration of the study and exhibited normal appearance and behaviour.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The sensitisation study was performed to investigate the allergenic potential of test article. The procedure was in two parts: induction and challenge. On the basis of the preliminary investigations, the following dose levels were selected: A concentration of 2.5% (w/w) was selected for the intradermal induction. A 50% (w/w) test concentration was chosen for the dermal induction and for the challenge application a 25% (w/w) test concentration was selected. The guinea pigs were challenged topically three weeks after the intradermal induction. No skin responses evaluated as positive were observed. In test and control groups sporadic grade 1 reactions to the vehicle were observed.The guinea pigs made normal body weight changes over the duration of the study and exhibited normal appearance and behaviour.
Therefore, under the experimental condition, test article did not cause allergenic response to guinea pigs.
Migrated from Short description of key information:
Test article was not considered to be a sensitizer to guinea pig based on the available data.
Justification for selection of skin sensitisation endpoint:
one study according to OECD guideline and GLP was available
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
In a guideline-compliant primary skin sensitisation study in guinea pigs, 2-ethylhexyl salicylate showed no skin sensitising properties. Therefore, 2-ethylhexyl salicylate does not have to be classified as a skin sensitizer according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).
For respiratory sensitisation no data is available.
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