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EC number: 247-161-5 | CAS number: 25646-71-3
- 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 sensitization (equivalent to OECD 406), guinea pig: sensitizing
Supporting studies (Exposure related observations in humans, sensitisation data humans, please refer to section 7.10.4): indications for sensitizing properties in humans
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- not specified
- Principles of method if other than guideline:
- The test was performed in 1988 according to the procedure described by Magnusson & Klingman 1969 when the OECD Guideline 406 adopted 1981 was the current version. According to this guideline "the Guinea Pig Maximisation Test (GPMT) was considered acceptable.
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The test was done before LLNA as first-choice method for in-vivo testing was set into force.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: JA Sahlin, Malmo, Sweden - Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- initial test: 0.25% intradermally and 20% in water topically
- Day(s)/duration:
- initial test: intradermal induction on day 0, topical induction on day 6, challenge on day 21
- Adequacy of induction:
- other: moderate irritant concentration
- Route:
- intradermal and epicutaneous
- Vehicle:
- petrolatum
- Concentration / amount:
- final test: 0.2% intradermally and 25% in petrolatum topically
- Day(s)/duration:
- final test: intradermal induction on day 0, topical induction on day 7, challenge on day 21
- Adequacy of induction:
- other: moderate irritant concentration
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: saline
- Concentration / amount:
- initial test: 1%
- Day(s)/duration:
- challenged on day 21; reactions read 48 and 72 h after application
- Adequacy of challenge:
- other: non-irritant concentration
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- final test: 0.5 and 0.1 mol/kg in petrolaum
- Day(s)/duration:
- challenged on day 21; reactions read 48 and 72 h after application
- Adequacy of challenge:
- other: non-irritant concentration
- No. of animals per dose:
- 21 animals in the initial test; 20 animals in the final test
- Details on study design:
- RANGE FINDING TESTS: Pre-testing for irritancy was carried out with separate animals using dilutions with both water and petroleum to establish concentrations at which moderate irritation and no irritation occured. These concentrations were used to determine the induction (moderate irritation) and challenge (no irritation) concentrations.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: One intradermal and one topical exposure
- Exposure period: initial test: intradermal induction on day 0, topical induction on day 6, challenge on day 21; final test: intradermal induction on day 0, topical induction on day 7, challenge on day 21
- Test groups: initial test: 21 treated animals and 21 negative control animals; final test: 20 treated animals and 20 negative control animals
- Control group: yes; saline and petrolatum
- Site: not reported
- Frequency of applications: the induction period consisted of 2 exposures
- Duration: initial test: intradermal induction on day 0, topical induction on day 6, challenge on day 21; final test: intradermal induction on day 0, topical induction on day 7, challenge on day 21
- Concentrations: initial test: 0.25% intradermally and 20% in water topically; final test: 0.2% intradermally and 25% in petrolatum topically
B. CHALLENGE EXPOSURE
- No. of exposures: One topical exposure
- Day(s) of challenge: challenged on day 21
- Exposure period: challenged on day 21; reactions read 48 and 72 h after application
- Test groups: initial test: 21 treated animals and 21 negative control animals; final test: 20 treated animals and 20 negative control animals
- Control group: yes; saline and petrolatum
- Site: not reported
- Concentrations: initial test: 1%; final test: 0.5 and 0.1 mol/kg in petrolaum
- Evaluation (hr after challenge): reactions read 48 and 72 h after application - Challenge controls:
- Saline and petrolatum
- Positive control substance(s):
- no
- Positive control results:
- Not applicable
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- initial test: 1% in saline
- No. with + reactions:
- 6
- Total no. in group:
- 21
- Clinical observations:
- not reported
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- other: solvent control
- Dose level:
- initial test: saline
- No. with + reactions:
- 0
- Total no. in group:
- 21
- Clinical observations:
- not reported
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- final test: 0.5 mol/kg in petrolatum
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- not reported
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- final test: 0.1 mol/kg in petrolatum
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- not reported
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- other: solvent control
- Dose level:
- final test: petrolatum
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Clinical observations:
- not reported
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- other: CLP/EU GHS Category 1 (H317) according to Regulation (EC) No 1272/2008
- Conclusions:
- In a published guinea pig maximization test, guinea pigs were induced with 0.25% CD-3 intradermally and 20% CD-3 in water topically in an initial test. Animals were then challenged with 1% of CD-3. In the final test, animals were induced with 0.2% CD-3 intradermally and 25% CD-3 in petrolatum topically. Animals were then challenged topically with 0.5 and 0.1 mol/kg in petrolaum. Results from the initial test showed that 6/21 animals showed a positive response to CD-3 at the 48 hour observation. All animals (n=20) in the final test showed sensitization for both dose levels. Based on these results, CD-3 was established as a skin sensitizer.
Reference
The 48 hour readings were reported without the 72 hour readings because there were only minor variations without statistically significant differences.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Skin sensitization (equivalent to OECD 406), guinea pig
In a guinea pig maximization test conducted in a similar manner to OECD 406, N-(2-(4-amino-N-ethyl-m-toluidino)ethyl)methanesulphonamide sesquisulphate (i.e., CD-3) was found to be a sensitizer (Liden and Boman, 1988). A group of 21 guinea pigs was intradermally dosed in an initial test with 0.25% CD-3 in water on day 0 and then topically with 20% CD-3 in water on day 6. On day 21, guinea pigs were then challenged with 1% of CD-3. In the final test, 20 guinea pigs were intradermally dosed in an initial test with 0.2% CD-3 in petrolatum on day 0 and then topically with 20% CD-3 in petrolatum on day 7. On day 21, guinea pigs were then challenged with 0.5 and 0.1 mol/kg CD-3 in petrolatum. Results from the initial test showed that 6/21 animals showed a positive response to CD-3 at the 48 hour observation. All animals (n=20) in the final test showed sensitization for both dose levels at the 48 hour observation. The 48 hour readings were reported without the 72 hour readings because there were only minor variations without statistically significant differences. Solvent controls responded appropriately. The publication did not report irritation results or systemic toxicity results. Based on these results, CD-3 was established as a skin sensitizer.
Supporting studies (Exposure related observations in humans, sensitisation data humans,section 7.10.4)
Three different human studies (Liden 1984, Liden 1989 and 1988) indicate that the photographic chemical CD-3 might have caused contact-allergy and lichenoid reactions in workers of a film laboratory.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the reliable data from the test material, N-(2-(4-amino-N-ethyl-m-toluidino)ethyl)methanesulphonamide, it is concluded that the data meet the criteria for skin sensitization category 1 (H317) according to Regulation (EC) 1272/2008. This finding is supported by human data showing contact allergy and lichenoid reactions in workers of a film laboratory.
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