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EC number: 204-111-7 | CAS number: 115-84-4
- 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
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:
- 4 April to 13 May 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline and GLP-compliant study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- Male albino guinea-pigs obtained from D. Hall, Newchurch. Staffordshire, England. They were approximately four to five weeks old and in a weight range of 301 to 339 g on arrival. The animal room temperature was maintained at 21°C with a relative humidity at 30-70%. Air exchange was maintained at 15 air changes/hour and lighting was controlled by a time switch to give 12 hours of artificial light (7:00 - 19:00) in each 24 hour period.
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: Alembicol D
- Concentration / amount:
- 2.5% v/v in Alembicol D (intradermal induction application)
100% (topical induction application)
100 % and 50% v/v in Alembicol D (topical challenge) - Route:
- epicutaneous, occlusive
- Vehicle:
- other: Alembicol D
- Concentration / amount:
- 2.5% v/v in Alembicol D (intradermal induction application)
100% (topical induction application)
100 % and 50% v/v in Alembicol D (topical challenge) - No. of animals per dose:
- 10 test animals
5 control animals - Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
3 pairs of intradermal injections: 1). Freund's complete adjuvant diluted with equal volume of water for irrigation (Ph. Eur.)
2). 2.5% BEPD v/v in Alembicol D
3). 2.5% BEPD v/v in a 50:50 mixture of Freund's complete adjuvant and Alembicol D.
6 days after the injections, the same site was shorn and pre-treated with 0.5 mL 10% w/w sodium lauryl sulphate in petroleum. 24 hours later, a patch saturated with 0.4 mL BEPD was applied and held in place for a further 48 hours.
- Test group: 10 animals
- Control group: 5 animals
B. CHALLENGE EXPOSURE
0.2 mL BEPD was applied to the anterior site. 50% BEPD v/v in Alembicol D was applied to the posterior site. The patches were held in place for 24 hours. - Challenge controls:
- None
- Positive control substance(s):
- yes
- Remarks:
- hexyl cinnamic aldehyde
- Positive control results:
- The results of regular studies with the positive control HCA (reliability checks) confirm the sensitivity of the test method (80-100% response).
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No signs of ill health or toxicity were recorded
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No signs of ill health or toxicity were recorded.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No signs of ill health or toxicity were recorded
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No signs of ill health or toxicity were recorded.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No signs of ill health or toxicity were recorded
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: No signs of ill health or toxicity were recorded.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No signs of ill health or toxicity were recorded
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: No signs of ill health or toxicity were recorded.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No signs of ill health or toxicity were recorded
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No signs of ill health or toxicity were recorded.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No signs of ill health or toxicity were recorded
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No signs of ill health or toxicity were recorded.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No signs of ill health or toxicity were recorded
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: No signs of ill health or toxicity were recorded.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No signs of ill health or toxicity were recorded
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: No signs of ill health or toxicity were recorded.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- No evidence of sensitisation was seen under the conditions of this study. BEPD does not require classification for skin sensitisation.
- Executive summary:
The potential of BEPD to induce delayed contact hypersensitivity (skin sensitisation) was investigated in a Maximisation test using male Dunkin-Hartley guinea-pigs. Concentrations used for induction and challenge applications were based on the results of a preliminary study. Intradermal injection was performed on test animals (10) using paired injections of the test material (2.5% BEPD v/v in Alembicol D, 2.5% BEPD v/v in a 50:50 mixture of Freund's Complete Adjuvant and Alembicol D) and FCA diluted with equal volume of water. Topical application was performed using 48 -hour occlusive application of the test material as supplied; local dermal irritation at the application site had previously been induced by topical application of 10% w/w sodium lauryl sulphate in petroleum. Control animals (5) were similarly treated during the induction phase, with vehicle in place of the test material. All test and control animals were challenged by 24 -hour occlusive application of the test material as supplied and as dilution (50% BEPD v/v in Alembicol D). No dermal reactions were observed at 24, 48 and 72 hours following the challenge application in test or control animals. No evidence of sensitisation was seen under the conditions of this study. BEPD does not require classification for skin sensitisation.
Reference
No reactions were observed in any group after challenge application with BEPD.
Dermal reactions observed after each induction:
Site |
Intradermal injections |
Topical applications |
||
|
Test animals |
Control animals |
Test animals |
Control animals |
1 |
Necrosis |
Necrosis |
Slight erythema |
Slight erythema |
2 |
Slight irritation |
Slight irritation |
||
3 |
Necrosis |
Necrosis |
1: 0.1 mL Freund’s complete adjuvant 50:50 with sterile water for irrigation (Ph. Eur.)
2: 0.1 mL 2.5% BEPD v/v in Alembicol D
3: 0.1 mL 2.5% v/v in a 50:50 mixture of Alembicol D and Freund’s complete adjuvant
Bodyweights
Group |
Guinea-pig number |
Day 1 18 April 1995 |
Last observation day 13 May 1995 |
Control |
1205 |
488 |
759 |
1206 |
440 |
585 |
|
1207 |
450 |
638 |
|
1208 |
453 |
597 |
|
1209 |
492 |
728 |
|
Test |
1210 |
477 |
723 |
1211 |
462 |
638 |
|
1212 |
464 |
665 |
|
1213 |
477 |
686 |
|
1214 |
443 |
639 |
|
1215 |
441 |
648 |
|
1216 |
475 |
644 |
|
1217 |
433 |
626 |
|
1218 |
436 |
603 |
|
1219 |
454 |
650 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
No evidence of skin sensitisation was seen in a guinea-pig Maximisation test performed with BEPD. There are no reports of skin sensitisation in exposed workers.
Migrated from Short description of key information:
A maximisation study is available for BEPD
Justification for selection of skin sensitisation endpoint:
Only one study available
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
No evidence of skin sensitisation was seen in a Maximisation test with BEPD and there are no reports of sensitisation in exposed workers. The substance does not therefore require classification as skin sensitiser under CLP
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