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EC number: 284-660-7 | CAS number: 84961-70-6
- 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
The key study (Murmann, P 1993) examined the potential of HAB to cause irritation to skin. The undiluted test substance (0.5 mL) was placed on the intact skin of 6 male rabbits for four hrs, and covered with a semi-occlusive patch. After four hrs, the test substance was removed with warm water. The animals were scored for signs of edema and erythema according to the Draize scale at 3/4, 24, 48, and 72 hrs. All animals showed signs of erythema (maximum score of 2) by the 3/4 hr observation. Five of the six animals also showed edema (maximum score of 2) at that reading as well. Erythema and edema persisted through the 72 hr reading, though by the 6 day reading only 2 animals showed signs of erythema, and one animal still showed signs of edema. By the day 8 reading, all signs of erythema and edema had resolved. At the 72 hr observation, one animal display yellowish, and drying and cracking skin. At the 6 day observation, this animal, along with 3 others showed shedding skin. By the 8 day observation, most of these animals still showed shedding skin, though it was healing. By the 10 day observation, all symptoms had resolved. Because symptoms were not fully resolved at the end of 72 hrs, the study was extended through 10 days after exposure. The primary irritation index was 1.25, and all symptoms were fully reversible. Therefore, HAB is not classified as a skin irritant according to CLP Regulation.
The key study (Murmann, P 1993) examined the potential of HAB to cause irritation to eyes. A 0.1 ml sample of undiluted test substance was placed in one eye of each of three male rabbits. The untreated eye served as control. The animals were examined for signs of irritation at 1, 24, 48, and 72 hours after application. All three animals showed signs of conjunctival erythema (score of 1) at the 1 hr observation. By the 48 hr observation, these symptoms had resolved in all but one animal. This animal continued to show irritation at the 72 hr observation. For this reason, the study was extended to determine the reversibility of the symptoms. At the next observation at day 6, symptoms had resolved in all animals. The mean irritation score was 0.55. Therefore, HAB is not classified as an eye irritant under CLP Regulation.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October 5, 1992-December 18, 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Fa. Dr. Karl Thomae GmbH, Biberach
- Age at study initiation: adult
- Weight at study initiation: 2-3 kg
- Housing: singly in stainless steel cages, identified by ear tags
- Diet (e.g. ad libitum): Ssniff K4, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 degree C
- Humidity (%): 30-70%
- Air changes (per hr): 15 changes/hr
- Photoperiod (hrs dark / hrs light): 12 hrs light/12 hrs dark
IN-LIFE DATES: From: December 12, 1992 To: December 18, 1992 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- There was one intact skin test site per animal. Each test site was treated with 0.5 mL of undiluted test material.
- Duration of treatment / exposure:
- 4 hrs
- Observation period:
- Observations for dermal irritation and defects occurred at 3/4, 24, 48, and 72 hours, and 6, 8, and 10 days after the occlusion period.
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: dorsal
- Type of wrap if used: Aesculap Favorita II
REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed with warm water
- Time after start of exposure: 4 hrs
SCORING SYSTEM: Draize - Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24, 48, and 72 hrs
- Score:
- 1.25
- Irritant / corrosive response data:
- All animals showed signs of erythema (maximum score of 2) by the 3/4 hr observation. Five of the six animals also showed edema (maximum score of 2) at that reading as well. Erythema and edema persisted through the 72 hr reading, though by the 6 day reading only 2 animals showed signs of erythema, and one animal still showed signs of edema. By the day 8 reading, all signs of erythema and edema had resolved. At the 72 hr observation, one animal display yellowish, and drying and cracking skin. At the 6 day observation, this animal, along with 3 others showed shedding skin. By the 8 day observation, most of these animals still showed shedding skin, though it was healing. By the 10 day observation, all symptoms had resolved.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The primary irritation index was 1.25 and all symptoms were fully reversible within 14 days. The test substance is not classified as a skin irritant according to EU GHS guidelines.
- Executive summary:
This study examined the potential of the test substance to cause irritation to skin. The test substance was placed on the skin of 6 male rabbits for 4 hrs, and covered with a semi-occlusive patch. After 4 hrs, the test substance was removed with warm water. The animals were scored for signs of edema and erythema according to the Draize scale at 3/4, 24, 48, and 72 hrs. Because symptoms were not fully resolved at the end of 72 hrs, the study was extended through 10 days after exposure. Signs of erythema (maximum score of 2) and edema (maximum score of 2) were seen at the 3/4 hr observation. These symptoms were fully resolved by the day 8 observation. Signs of discoloration, drying and cracking were seen starting at the 72 hr observation. By the day 10 observation, all of these symptoms were resolved as well. The primary irritation index was 1.25, and all symptoms were fully reversible. The test substance is therefore not classified as a skin irritant according to EU GHS guidelines.
Reference
Results of Skin Irritation Study
Animal |
1 |
2 |
3 |
4 |
5 |
6 |
Erythema |
||||||
¿ hr |
2 |
1 |
2 |
1 |
2 |
2 |
24 hrs |
2 |
2 |
1 |
2 |
2 |
1 |
48 hrs |
2 |
2 |
1 |
1 |
2 |
1 |
72 hrs |
3 |
2 |
1 |
2 |
3 |
1 |
6 days |
2 |
0 |
0 |
0 |
1 |
0 |
8 days |
0 |
0 |
0 |
0 |
0 |
0 |
10 days |
0 |
0 |
0 |
0 |
0 |
0 |
Edema |
||||||
¿ hr |
1 |
1 |
2 |
1 |
1 |
0 |
24 hrs |
1 |
1 |
1 |
1 |
1 |
0 |
48 hrs |
1 |
1 |
0 |
1 |
1 |
0 |
72 hrs |
2 |
1 |
0 |
1 |
1 |
0 |
6 days |
1 |
0 |
0 |
0 |
0 |
0 |
8 days |
0 |
0 |
0 |
0 |
0 |
0 |
10 days |
0 |
0 |
0 |
0 |
0 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Fa. Dr. Karl Thomae GmbH, Biberach
- Age at study initiation: adult
- Weight at study initiation: 2-3 kg
- Housing: individually in stainless steel cages, identified by ear tags
- Diet (e.g. ad libitum): Ssniff K 4, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 degree C
- Humidity (%): 30-70%
- Air changes (per hr): 15 air changes/hr
- Photoperiod (hrs dark / hrs light): 12 hrs light/12 hrs dark
IN-LIFE DATES: From: Oct. 19, 1992 To: Oct. 26, 1992 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye was used as control.
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
24 hrs- Observation period (in vivo):
- Readings were taken at 1, 24, 48, and 72 hours, and 6 days after the application.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- A single application to the conjunctival sac of the right eyelid. The substance was not washed out.
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: fluorescein stain - Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 24, 48, and 72 hrs
- Score:
- 0.55
- Reversibility:
- fully reversible within: 6 days
- Irritant / corrosive response data:
- All three animals exhibited conjunctival erythema (score of 1) at the 1 hr reading and through the 24 hr reading. By the 48 hr reading, these symptoms had resolved in all but one animal. This animal continued to show conjunctival erythema through the 72 hr reading, but by the day 6 reading, its symptoms had resolved as well.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance is not classified as an eye irritant according to EU GHS guidelines.
- Executive summary:
This study examined the potential of the test substance to cause irritation to eyes. 0.1 ml of test substance was placed in one eye of three male rabbits. The untreated eye served as control. The animals were examined for signs of irritation at 1, 24, 48, and 72 hours after application. All three animals showed signs of conjunctival erythema (score of 1) at the 1 hr observation. By the 48 hr observation, these symptoms had resolved in all but one animal. This animal continued to show irritation at the 72 hr observation. For this reason, the study was extended to determine the reversibility of the symptoms. At the next observation at day 6, symptoms had resolved in all animals. The mean irritation score was 0.55. The test substance is not classified as an eye irritant under EU GHS guidelines.
Reference
Results of Eye Irritation Study
Animal |
1 hr |
24 hr |
48 hr |
72 hr |
6 days |
|
1 |
Conjunctiva - Erythema |
1 |
1 |
1 |
1 |
0 |
Conjunctiva ¿ Chemosis |
0 |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
0 |
|
Cornea |
0 |
0 |
0 |
0 |
0 |
|
2 |
Conjunctiva - Erythema |
1 |
1 |
0 |
0 |
0 |
Conjunctiva ¿ Chemosis |
0 |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
0 |
|
Cornea |
0 |
0 |
0 |
0 |
0 |
|
3 |
Conjunctiva - Erythema |
1 |
1 |
0 |
0 |
0 |
Conjunctiva ¿ Chemosis |
0 |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
0 |
|
Cornea |
0 |
0 |
0 |
0 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
HAB is not irritating to the skin or eyes of laboratory animals; inhalation is not a relevant route of exposure.
Justification for selection of skin irritation / corrosion
endpoint:
Key guideline study reports experimental data.
Justification for selection of eye irritation endpoint:
Key guideline study reports experimental data.
Justification for classification or non-classification
HAB is not irritating to the skin or eyes of laboratory animals in a GLP study; inhalation is not a relevant route of exposure.
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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