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EC number: 284-366-9 | CAS number: 84852-53-9
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was performed on the commercial SAYTEX 8010 Flame Retardant product under international guidelines and GLPS.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 007
- Reference Type:
- publication
- Title:
- Allergic Contact Dermatitis in the Guinea Pig
- Author:
- Magnusson and Kligman
- Year:
- 1 970
- Bibliographic source:
- Charles C. Thomas, Springfield, IL
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The assay was originally run for the US registration.
Test material
- Reference substance name:
- 1,1'-(ethane-1,2-diyl)bis[pentabromobenzene]
- EC Number:
- 284-366-9
- EC Name:
- 1,1'-(ethane-1,2-diyl)bis[pentabromobenzene]
- Cas Number:
- 84852-53-9
- Molecular formula:
- C14H4Br10
- IUPAC Name:
- 1,2,3,4,5-pentabromo-6-[2-(2,3,4,5,6-pentabromophenyl)ethyl]benzene
- Details on test material:
- The commercial SAYTEX 8010 Flame Retardant product was used as test article. The composition was 98.34% DBDPEthane and 1.66% Nonabromodiphenyl ethane.
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Raliegh NC
- Females (if applicable) nulliparous and non-pregnant: 5, Males 5 (4 males, 4 females for preliminary study); 23 males and females for second experiment
- Age at study initiation: 2 months
- Weight at study initiation: males: 263-318 g, females 262-301 g
- Housing: Suspended stainless steel cages, wire mesh floor
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitumn
- Acclimation period: 7 days
- Indication of any skin lesions: no
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 22 deg C
- Humidity (%): 32 to 68%
- Photoperiod (hrs dark / hrs light): 12 h
- IN-LIFE DATES: From: To: Sept. 24 to Oct. 29 2002
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- negative control
- Concentration / amount:
- O.5% CMC in water : 50% FCA. id induction day 1.
- Route:
- intradermal
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- positive control
- Concentration / amount:
- 0.5 % CMC in water: 5%, FCA 50%, mixture of 5% HCA in 50% FCA. i.d. induction day 1
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- intradermal
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- Test substance
- Concentration / amount:
- 50% FCA, 5% Test substance in 0.5% CMC in water, test site 3 mixture of 5% test substance in 50% FCA
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- Vehicle control
- Concentration / amount:
- 0.5 % in water on day 8
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- positive control
- Concentration / amount:
- 100% HPA on day 8
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- Test substance
- Concentration / amount:
- 100% on day 8
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- irritation control
- Concentration / amount:
- Control animals: left flank 1% Test substance in 0.5% methylcellulose solution in water, right flank 0.5 % methylcellulose. Day 22
- Adequacy of challenge:
- highest non-irritant concentration
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: mineral oil
- Remarks:
- positive control
- Concentration / amount:
- Left Flank: 50% HPA in mineral oil, right flank: mineral oil, Day 22
- Adequacy of challenge:
- highest non-irritant concentration
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- Test substance
- Concentration / amount:
- Left flank: 1% testsubstance in 0.5% CMC, right flank 0.5% CMC in water. Day 22
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10 in each of the control and positive control groups
20 in the test group - Details on study design:
- Test group: 1% test article in 0.5% methylcellulose to left flank; 0.5% methylcellulose to right flank.
For the challenge phase, reactions at the test article or positive control treated sites greater than those seen at the vehicle treated sites were considered indicative of a sensitization response. In general, scores of 1 or greater at the test sites indicated sensitization, provided grades of less than 1 were seen at the control sites. If scores of 1 or greater were noted at the control sites; then reactions a test sites that exceeded the most severe control reactions were presumed due to sensitization.
A comparison of the reactions elicited in terms of incidence, severity, and duration between the control, positive control, and test groups was conducted to dtermine whether the test article induced sensitization. In order to interpret the responses, three indices were used: severity index (SI), incidence index (II), and sensistization index (SII). The SI was determine dfor both the 24 and 48 hr scores by dividing the sum of grades in the a group by the total number of animals in that group. The II was the fraction of animals showing a ositive sensitization response at 24 or 48 hours (animals showing a positive response at both observations were counted as one incidence). The SII was the percentage of animals showing a a positive response at 24 or 48 hours (animals showing a positive response at both observations were counted as one incidence). Classification of senzitization potential was determined using the scale below per Magnusson and Kligman (1970). - Challenge controls:
- Control: 1% test article in 0.5% methylcellulose) to left flank; 0.5% methylcellulose to right flank.
Positive control: 50% HCA in mineral oil to left flank; mineral oil to right flank. - Positive control substance(s):
- yes
- Remarks:
- 50% HCA (alpha-hexylcinnamaldehyde, 85%)
Results and discussion
- Positive control results:
- During the challenge (maximization) phase of the study, the positive control group responded in a normal manner with approximately 90% of the animals observed with scattered mild erythema (severity score = 1) at the 24 hour observation interval.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: irritation control, test substance in uninduced control animals
- Dose level:
- 1% DBDPEthane in CMC; left flank on uninduced control animals
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Clinical observations:
- scattered mild erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 1% DBDPEthane in CMC; left flank. No with. + reactions: 9.0. Total no. in groups: 10.0. Clinical observations: scattered mild erythema.
- Remarks:
- Test substance caused irritation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- CMC; right flank
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- scattered mild erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: CMC; right flank. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: scattered mild erythema.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 50% HCA in mineral oil; left flank
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Clinical observations:
- scattered mild erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 50% HCA in mineral oil; left flank. No with. + reactions: 9.0. Total no. in groups: 10.0. Clinical observations: scattered mild erythema.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: posiive control vehicle
- Dose level:
- mineral oil; right flank
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- scattered mild erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: mineral oil; right flank. No with. + reactions: 2.0. Total no. in groups: 10.0. Clinical observations: scattered mild erythema.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1% DBDPEthane in CMC; left flank
- No. with + reactions:
- 16
- Total no. in group:
- 20
- Clinical observations:
- scattered mild erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1% DBDPEthane in CMC; left flank. No with. + reactions: 16.0. Total no. in groups: 20.0. Clinical observations: scattered mild erythema.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: test chemcial group vehicle control site
- Dose level:
- CMC; right flank
- No. with + reactions:
- 8
- Total no. in group:
- 20
- Clinical observations:
- scattered mild erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: CMC; right flank. No with. + reactions: 8.0. Total no. in groups: 20.0. Clinical observations: scattered mild erythema.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: irritation control, test chemical in uninduced animals
- Dose level:
- 1% DBDPEthane in CMC; left flank
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- scattered mild erythema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 1% DBDPEthane in CMC; left flank. No with. + reactions: 2.0. Total no. in groups: 10.0. Clinical observations: scattered mild erythema.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: test chemical group vehicle control site
- Dose level:
- CMC, right flank
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- scattered mild erythema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: CMC, right flank. No with. + reactions: 2.0. Total no. in groups: 10.0. Clinical observations: scattered mild erythema.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 50% HCA in mineral oil; left flank
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Clinical observations:
- scattered mild erythema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 50% HCA in mineral oil; left flank. No with. + reactions: 5.0. Total no. in groups: 10.0. Clinical observations: scattered mild erythema.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: positive control vahicle control site
- Dose level:
- mineral oil; right flank
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- scattered mild erythema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: mineral oil; right flank. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: scattered mild erythema.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1% DBDPEthane in CMC; left flank
- No. with + reactions:
- 4
- Total no. in group:
- 20
- Clinical observations:
- scattered mild erythema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1% DBDPEthane in CMC; left flank. No with. + reactions: 4.0. Total no. in groups: 20.0. Clinical observations: scattered mild erythema.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: test chemical group vehicle control site
- Dose level:
- CMC; right flank
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Clinical observations:
- scattered mild erythema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: CMC; right flank. No with. + reactions: 5.0. Total no. in groups: 20.0. Clinical observations: scattered mild erythema.
Any other information on results incl. tables
Summary of Dermal Scores (Challenge) – Male and Female
Group |
# GP |
Total 24 Hr Score |
Total 48 Hr Score |
# w/scores ≥1 at 24 or 48 hr |
Severity Index (SI) |
Incidence Index (II) |
Sensitization Index (SII) |
|
24 Hr |
48 Hr |
|||||||
Control |
||||||||
L Flank |
10 |
9 |
2 |
9 |
0.9 |
0.2 |
9/10 |
90% |
R Flank* |
10 |
1 |
2 |
2 |
0.1 |
0.2 |
2/10 |
20% |
Positive Control |
||||||||
L Flank |
10 |
9 |
5 |
9 |
0.9 |
0.5 |
9/10 |
90% |
R Flank |
10 |
2 |
1 |
2 |
0.2 |
0.1 |
2/10 |
20% |
Test |
||||||||
L Flank |
20 |
18 |
4 |
16 |
0.9 |
0.2 |
16/20 |
80% |
R Flank |
20 |
8 |
5 |
9 |
0.4 |
0.25 |
9/20 |
45% |
* Right flank treated with vehicle only (control & test vehicle = CMC; positive control vehicle = mineral oil). In the irritation control groups it does not make sense to calculate the sensitization index. The results indicate that the test substance caused irritaiton in particular in the 24 h reading, that disappeared after 48 h. The severity and incidence was comparble in the control animals that were not induced with the test substance and in the iduced group. This demonstrates that the reactions are not a skin sensitization reaction, but an irritation.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- DBDPEthane was not a skin sensitizer when tested in the guinea pig maximization test. Upon challenge, the responses in the test animals were similar to those in the control group.
- Executive summary:
DBDPEthane was not a skin sensitizer when tested in the guinea pig maximization test. Upon challenge, the responses in the test animals were similar to those in the control group.
No test-article-related mortalities occurred. Body weights were normal for the age and species. Group mean body weights increased during the study.
During the intradermal irritation screen, scattered mild erythema was observed at the 4 and 5% concentration sites in all animals at both observation intervals. Scattered mild erythema was observed at the 0.5, 1 and 2% concentration sites in two of four animals at one or both observation intervals. Two animals did not exhibit any erythema at the 0.5 and 1% concentration sites. During the topical patch irritation screen, scattered mild erythema was observed in one of four animals at the 50% concentration site (24 hours only) and in two of four animals at the 75% concentration site (24 hours only). Therefore, based on the irritation screen results, the test article was used at 5% in 0.5% methylcellulose for the intradermal injection induction, 100% for the topical patch induction, and 1% in 0.5% methylcellulose for the challenge exposure.
During the challenge (maximization) phase of the study, the positive control group responded in a normal manner with approximately 90% of the animals observed with scattered mild erythema (severity score = 1) at the 24 hour observation interval. In the control group, scattered mild erythema was observed at the test article sites in nine of ten animals at 24 hours (90%) and two of ten animals (20%) at 48 hours. In the test group, scattered mild erythema (severity score = 1) was observed in fourteen of twenty animals at 24 hourspostdose (70%) and in four of twenty animals at 48 hours postdose (20%). Moderate and diffuse erythema (severity score = 2) was observed in two of twenty animals at 24 hours postdose (10%). Test group dermal observations of the vehicle sites (right flank) were similar to those seen in the control group.
No other clinical signs were observed in any animal.
Under the conditions of this study, because the severity and sensitization indices were approximately the same for the control and test groups, it was concluded that the test article was not a sensistizer in guinea pigs.
Summary of Dermal Scores (Challenge) – Male and Female
Group
# GP
Total 24 Hr Score
Total 48 Hr Score
# w/scores ≥1 at 24 or 48 hr
Severity Index (SI)
Incidence Index (II)
Sensitization Index (SII)
24 Hr
48 Hr
Control
L Flank
10
9
2
9
0.9
0.2
9/10
90%
R Flank*
10
1
2
2
0.1
0.2
2/10
20%
Positive Control
L Flank
10
9
5
9
0.9
0.5
9/10
90%
R Flank
10
2
1
2
0.2
0.1
2/10
20%
Test
L Flank
20
18
4
16
0.9
0.2
16/20
80%
R Flank
20
8
5
9
0.4
0.25
9/20
45%
* Right flank treated with vehicle only (control & test vehicle = CMC; positive control vehicle = mineral oil).
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.