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EC number: 294-785-9 | CAS number: 91770-03-5
- 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 October 2000 - 7 November 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Fatty acids, tall-oil, reaction products with boric acid (H3BO3) and diethanolamine
- EC Number:
- 294-785-9
- EC Name:
- Fatty acids, tall-oil, reaction products with boric acid (H3BO3) and diethanolamine
- Cas Number:
- 91770-03-5
- IUPAC Name:
- Fatty acids, tall-oil, reaction products with boric acid (H3BO3) and diethanolamine
- Details on test material:
- - Physical state: light orange liquid
- Analytical purity: Not specified
- Stability under test conditions: Not specified
- Storage condition of test material: Room temperature and humidity
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: ca. 3 months Animals born on 2000-07-15
- Weight at study initiation: 2.0 - 2.7 kg
- Housing: Suspended wire cages, 1 rabbit/cage
- Water (e.g. ad libitum): ad libitum
- Acclimation period: Quarantine period of 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): controlled environment, but no information provided
- Humidity (%): controlled environment, but no information provided
- Air changes (per hr): controlled environment, but no air change information provided
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
IN-LIFE DATES: From: 2000-10-24 To: 2000-11-07
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 mL/rabbit (2.5 x 2.5 cm area)
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 3 rabbits ( 2 males, 1 female)
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: No data
- Type of wrap if used: 4 ply surgical gauze patch secured with non-irritating tape. The torso was wrapped with plastic in a semi-occlusive manner and secured with non-irritating tape which completely covered the plastic.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): With distilled water on removal of wrapping.
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritant / corrosive response data:
- Erythema was barely perceptible at 60 minutes following patch removal, well defined at 24 and 48 hours, well defined to moderate at 72 hours, absent to severe on day 7 and absent by day 14. Oedema was barely perceptible at 60 minutes following patch removal, well defined to moderate at 24 hours, barely perceptible to well-defined at 48 and 72 hours, absent to well defined on day 7 and absent by day 14.
- Other effects:
- There were no abnormal systemic signs noted during the observation period.
Bodyweight changes were normal.
Any other information on results incl. tables
Table 1: Dermal observations, body weights and systemic observation
Rabbit Ear-tag |
F5983 |
F5990 |
F5955 |
Sex |
M |
F |
M |
Pre-test body weight (kg) |
2.7 |
2.0 |
2.7 |
72 h weight (kg) |
2.7 |
2.0 |
2.8 |
Day 7 weight (kg) |
2.7 |
2.1 |
2.8 |
Terminal body weight (kg) |
2.8 |
2.2 |
2.8 |
Time after patch removal |
Erythema and Eschar Formation |
||
60 mins |
1 |
1 |
1 |
24 hours |
2 |
2 |
2 |
48 hours |
2 |
2b* |
2 |
72 hours |
3 |
2p |
2p |
7 days |
1f* |
4f* |
0f |
14 days |
0* |
0* |
0 |
|
Oedema |
||
60 mins |
1 |
1 |
1 |
24 hours |
2 |
2 |
3 |
48 hours |
1 |
2 |
2 |
72 hours |
1 |
2 |
2 |
7 days |
1 |
2 |
0 |
14 days |
0 |
0 |
0 |
|
Systemic Observations |
||
60 mins |
A |
A |
A |
24 hours |
A |
A |
A |
48 hours |
A |
A |
A |
72 hours |
A |
A |
A |
7 days |
A |
A |
A |
14 days |
A |
A |
A |
A = normal, b = brown areas, f = flaking skin, p = pale areas, *= reclipped
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Conclusions:
- In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is not required for dermal irritation as the findings do not meet the criteria for classification as Category 2: Irritant; i.e. mean scores are less than the minimum classification score of 2.3 for erythema and oedema, effects are reversible within 14 days and there are no indications of variability of response amongst the test animals.
- Executive summary:
Test Guidance
In accordance with EPA guideline OPPTS 870.2500
Method and Material
Three New Zealand White rabbits were dosed dermally with 0.5 mL of the test material to one intact site per rabbit. Semiocclusive wrapping was applied for 4 hours after which the wrapping was removed and the test site washed. Dermal reactions were scored using the Draize method at 60 minutes, 24, 48 and 72 hours and on days 7 and 14 of the observation period. The skin was also evaluated for ulceration, necrosis or evidence of skin destruction.
Results
Erythema was barely perceptible at 60 minutes following patch removal, well-defined at 24 and 48 hours, well-defined to moderate at 72 hours, absent to severe on day 7 and absent by day 14. Edema was barely perceptible at 60 minutes following patch removal, well-defined to moderate at 24 hours, barely perceptible to well-defined at 48 and 72 hours, absent to well-defined on day 7 and absent by day 14. Bodyweights were recorded pre-test and termination. There were no abnormal systemic signs noted during the observation period and body weight changes were normal.
Conclusion
In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is not required for dermal irritation as the findings do not meet the criteria for classification as Category 2: Irritant; i.e. mean scores are less than the minimum classification score of 2.3 for erythema and oedema, effects are reversible within 14 days and there are no indications of variability of response amongst the test animals.
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