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EC number: 482-110-2 | 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
Endpoint summary
Administrative data
Description of key information
Under the conditions of this study, the test material is considered to be a strong skin sensitizer as 75 % of the animals treated exhibited discrete to moderate erythema at the Challenge exposure following an Induction Phase.
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:
- 25 November 2003 to 20 December 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Version / remarks:
- 2003
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- US EPA GLP, 40 CFR, Part 792 and OECD GLP
- Type of study:
- Freund's complete adjuvant test
- Justification for non-LLNA method:
- Currently no LLNA study is available for assessment. The Freund's complete adjuvant test has been carried out as an animal test to predict human sensitization for over a decade and is recommended by international test guidelines such as OECD.
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- Male and female Hartley guinea pigs weighed 302.2 to 496.4 g and were at least 21 days old. They were group-housed upon arrival in stainless steel suspended cages. The animals were acclimated for at least 5 days prior to dosing. Water and feed were provided ad libitum. The temperature and humidity were maintained at 68 ± 5 °F and 30 - 70 %, respectively. Room lights were on a 12-hour light/dark cycle.
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- 50% test substance for intradermal induction
100% for topical induction (occlusive) - Day(s)/duration:
- Intradermal induction on Day 0, topical induction on Day 7 (48 hour exposure)
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 75% for topical challenge
- Day(s)/duration:
- Challenge on Day 21 (24 hour exposure)
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10/sex Test group (50% test substance intradermal; 100% test substance topical induction and 75% test substance topical challenge)
5 males/5 females Negative control group
2 males/3 females Positive control group
Primary irritation: 1/sex each for intradermal and topical - Details on study design:
- The application sites were prepared by clipping the skin of the test site free of hair. On day 0 and day 7, an approximately 5 x7 cm area over the shoulder region was prepared. On day 21, an approximately 4 x 4 cm square of the flank was prepared.
Before the start of the Induction Phase, two Preliminary Irritancy tests were conducted, in which it was determined that 50% test substance in water was the highest intradermal dose that did not illicit strong local or systemic reactions. The test substance was applied at the minimal topical irritating concentration, 100%, for the topical induction. For the topical challenge, the test substance was applied at the highest non-irritating concentration, 75% test substance in water.
On Day 0, for the intradermal induction, three pairs of intradermal injections were made so that on either side of the midline in the shoulder region there were three injection sites. The six injection sites were just within the boundaries of 2 x 4 cm. The dosing solutions were as follows:
Experimental Group
Injection Pair 1: 0.1 mL FCA 1:1 with Water for Injection
Injection Pair 2: 0.1 mL test substance
Injection Pair 3: 0.1 mL test substance 1:1 with FCA
Negative Control Group
Injection Pair 1: 0.1 mL FCA 1:1 with Cottonseed Oil (CSO)
Injection Pair 2: 0.1 mL CSO
Injection Pair 3: 0.1 mL 50% formulation of vehicle 1:1 with FCA
Positive Control Group
Injection Pair 1: 0.1 mL FCA 1:1 with CSO
Injection Pair 2: 0.1 mL 0.1% Benzocaine in 95% EtOH
Injection Pair 3: 0.1 mL 0.1% Benzocaine in 95% EtOH 1:1 with FCA
The benzocaine was dissolved in 95% ethanol and suspended in FCA to a final concentration of 0.1%.
On Day 7, for the topical induction, the experimental group was dosed with 100% the test substance. As the test substance was an irritant, the area was not pretreated with 0.5 mL of 10% sodium lauryl sulfate 24 hours prior to topical induction application. The test substance was spread over a 2 x 4 cm piece of filter paper in a thick even layer. The patch was placed on the dorsal surface of the animals, covered by an impermeable sheet, and secured with a non-adhesive bandage which was wound around the torso of the animal. The dressing was left in place for 48 hours. The negative control group was treated in a similar fashion with CSO instead of the test substance. The positive control group was exposed to 0.1% Benzocaine in 95% EtOH instead of the test substance.
On Day 21, for the topical challenge, pieces of filter paper measuring 2 x 2 cm were secured to the flanks for 24 hours, utilizing the same wrapping technique as previously described for the topical induction. For both the test and negative control groups, one patch was placed on the left side with the test substance at 75% and the second patch was placed on the right side with the vehicle alone. For the positive control animals, the patch on the left side was saturated with 0.1% Benzocaine in ethanol instead of the test substance.
Approximately 21 hours after patch removal, the flank skin was cleaned and clipped. Approximately 3 hours later, the first reading of the reactions was performed (Day 23) and the second reading was made on Day 24. For evaluation of skin reactions, the following four-point scale was used:
0 = No reactions
1 = Discrete or patchy erythema
2 = Moderate and confluent erythema
3 = Intense erythema and swelling
Daily observations were made for clinical signs of toxicity. Animals were weighed at the beginning and end of the observation period (Days 0 and 24). - Challenge controls:
- Negative control: Cottonseed Oil
Positive contro: Benzocaine - Positive control substance(s):
- yes
- Remarks:
- Benzocaine (CAS # 94-09-7); white solid
- Positive control results:
- The positive control animals exhibited skin reactions at each observation point (100% sensitized).
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 15
- Total no. in group:
- 20
- Clinical observations:
- No systemic signs of toxicity were observed
- Remarks on result:
- other: 75% sensitisation rate
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 13
- Total no. in group:
- 20
- Clinical observations:
- No systemic signs of toxicity were observed
- Remarks on result:
- other: 65% still appearing sensitised
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- CSO
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No systemic signs of toxicity were observed
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- CSO
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No systemic signs of toxicity were observed
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.1% Benzocaine in 95% EtOH
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Clinical observations:
- No systemic signs of toxicity were observed
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.1% Benzocaine in 95% EtOH
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Clinical observations:
- No systemic signs of toxicity were observed
- Remarks on result:
- positive indication of skin sensitisation
- Interpretation of results:
- other: EU Criteria: Category 1: May cause an allergic skin reaction.
- Conclusions:
- Under the conditions of this study, the test material is considered to be a strong skin sensitizer as 75 % of the animals treated exhibited discrete to moderate erythema at the Challenge exposure following an Induction Phase.
- Executive summary:
The skin sensitisation potential of the test material was investigated in accordance with the standardised guidelines OECD 406 and EPA OPPTS 870.2600, under GLP conditions.
Based on the results of the Primary Irritation study, the test material was applied at the minimal irritating dose for induction and the maximal non-irritating dose for challenge.
Under the conditions of the study, the test material elicited discrete to moderate erythema to the Challenge in the skin sensitisation Kligman Maximisation Test. Fifteen out of twenty of the test animals (75 % sensitisation) exhibited discrete to moderate erythema at the Challenge exposure following an Induction Phase and therefore the test material is considered to be a strong sensitiser.
All animals gained weight over the course of the study. No systemic signs of toxicity were observed in any animal over the course of the study. None of the negative control animals exhibited any reaction to the challenge. The positive control animals exhibited skin reactions at each observation point (100% sensitized).
Reference
All animals gained weight over the course of the study. No systemic signs of toxicity were observed in any animal over the course of the study. None of the negative control animals exhibited any reaction to the challenge. The positive control animals exhibited skin reactions at each observation point (100% sensitized).
In the main study, 15/20 animals (75% sensitization rate) exhibited discrete to moderate erythema at the 24 hour observation following the challenge application. At 48 hours following the challenge application, 13/20 were still exhibiting signs of erythema.
Skin Examination Results for the Test Group Challenged at 75% test substance |
|||
Animal Number |
Sex |
Hours After Challenge |
|
24 Hours |
48 Hours |
||
1 |
Male |
1 |
1 |
2 |
0 |
0 |
|
3 |
2 |
1 |
|
4 |
0 |
0 |
|
5 |
0 |
0 |
|
6 |
2 |
1 |
|
7 |
1 |
1 |
|
8 |
1 |
1 |
|
9 |
1 |
1 |
|
10 |
0 |
0 |
|
11 |
Female |
1 |
1 |
12 |
2 |
1 |
|
13 |
1 |
1 |
|
14 |
2 |
0 |
|
15 |
1 |
1 |
|
16 |
0 |
0 |
|
17 |
2 |
1 |
|
18 |
1 |
1 |
|
19 |
2 |
2 |
|
20 |
1 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
The skin sensitisation potential of the test material was investigated in accordance with the standardised guidelines OECD 406 and EPA OPPTS 870.2600, under GLP conditions. The study was awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997).
Based on the results of the Primary Irritation study, the test material was applied at the minimal irritating dose for induction and the maximal non-irritating dose for challenge.
Under the conditions of the study, the test material elicited discrete to moderate erythema to the Challenge in the skin sensitisation Kligman Maximisation Test. Fifteen out of twenty of the test animals (75 % sensitisation) exhibited discrete to moderate erythema at the Challenge exposure following an Induction Phase and therefore the test material is considered to be a strong sensitiser.
All animals gained weight over the course of the study. No systemic signs of toxicity were observed in any animal over the course of the study. None of the negative control animals exhibited any reaction to the challenge. The positive control animals exhibited skin reactions at each observation point (100% sensitized).
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No 1272/2008, the substance is classified as Category 1: May cause an allergic skin reaction (H317).
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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