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EC number: 203-055-0 | CAS number: 102-79-4
- 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

Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1967
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to an acceptable BASF-test which in principle is similar to OECD 405 (1981), with some deviations (the eyes were not washed out after 24 h); GLP was not compulsory at the time the study was conducted.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 967
- Report date:
- 1967
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1981
- Deviations:
- yes
- Remarks:
- eyes were not washed out after 24 h of treatment
- Principles of method if other than guideline:
- BASF Test:
Before OECD guideline 405 was established, eye irritation was tested using an BASF internal method. White Vienna rabbits were used. Usually approximately 50 µL of the unchanged test material were applied into the conjunctival sac of one eye of each of 2 animals. The non- or saline- treated eye served as control. The animals were observed several times on the treatment day and up to 8 days afterwards, and findings were recorded on working days. The eyes were not washed out after 24 h as specified in OECD Guideline 405. - GLP compliance:
- no
- Remarks:
- GLP was not compulsory at the time the study was conducted
Test material
- Reference substance name:
- 2,2'-butyliminodiethanol
- EC Number:
- 203-055-0
- EC Name:
- 2,2'-butyliminodiethanol
- Cas Number:
- 102-79-4
- Molecular formula:
- C8H19NO2
- IUPAC Name:
- 2-[butyl(2-hydroxyethyl)amino]ethan-1-ol
- Details on test material:
- - Name of test material (as cited in study report): Butyldiäthanolamin
- Physical state: liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- Weight at study initiation: 3.19 and 2.83 kg
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the second eye was treated with NaCl
- Amount / concentration applied:
- 0.05 mL
- Duration of treatment / exposure:
- The test substance were applied unchanged to the rabbit eyes, and the eyes were not washed out.
The eyes were examined after - Observation period (in vivo):
- 8 days
reading time points: after 10 minutes, 1 h, 3 h, 24 h, 48 h and 72 h, and at day 6, 7 and 8. - Number of animals or in vitro replicates:
- one male and one female animal
- Details on study design:
- Following application, the animals were examined for corneal changes, iris effects and conjunctival reaction at the reading time points mentioned above. The eye findings, which had been originally scored according to a BASF scoring system were re-evaluated according to the Draize Scoring System.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: same finding at all reading time points given above
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks on result:
- other: same finding at all reading time points given above
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- other: constricted pupil, bleeding, detachment of the upper skin layer, bloody discharge, grey-brown signs of corrosion; same findings at all reading time points given above
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: slight swelling, same finding at all reading time points given above
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: same finding at all reading time points given above
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks on result:
- other: same finding at all reading time points given above
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- other: constricted pupil, bleeding, detachment of the upper skin layer, bloody discharge, grey-brown signs of corrosion; same findings at all reading time points given above
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: swelling, same finding at all reading time points given above
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of the 2 animals
- Time point:
- 24/48/72 h
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of the 2 animals
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of the 2 animals
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of the 2 animals
- Time point:
- 24/48/72 h
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritant / corrosive response data:
- Animal 1:
At day 6, findings were as already described with in addition, scarring at the upper eyelid.
At day 7, findings were as already described with in addition, scarring at the upper eyelid, conjunctiva becoming grey-white, bleeding, slight to milky opacity of the cornea, and vascular ingrowth.
At day 8, findings were as reported above, with in addition onset of staphyloma; thus there was no evidence for reversibility of the findings.
Control eyes treated with physiological saline remained free from effects.
Animal 2:
At day 6, findings were as already described with in addition, scarring at the upper eyelid, slight to milky opacity of the cornea, vascular ingrowth and onset of staphyloma.
At day 7, findings were similar as for day 6.
At day 8, findings were as reported above, with clear staphyloma; thus there was no evidence for reversibility of the findings.
Control eyes treated with physiological saline remained free from effects.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- CLP: Cat 1
DSD: R 34 - Executive summary:
Butyldiethanolamine was tested for eye irritation in the rabbit according to an internal BASF method, which in principle was similar to the OECD TG 405 (1981). Approximately 50 µL of the unchanged test material were applied into the conjunctival sac of one eye of each of 2 rabbits. The saline-treated eye served as control.The animals were observed several times on the treatment day and up to 8 days afterwards, and findings were recorded on working days. The eyes were not washed out after 24 h as specified in OECD Guideline 405. The findings were evaluated according to the Draize Scoring System.
The instillation of the test material into the eye of rabbit resulted in severe irreversible lesions.
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