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EC number: 263-502-0 | CAS number: 62314-22-1
- 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
2017 LLNA pre-test: The observations in the OECD 429 LLNA pretests are indicative of the substances being corrosive.
Scores of =/> 3 were observed at concentrations 50, 25 and 10%
Ear swelling was greater than 25% in substance 1833500 at 25 and 50%
Body weight loss (>5%) was observed possibly indicative of systemic toxicity.
The main argument for not continuing with the main LLNA studies is the interpretation of the study director with regard to eschar formation at all concentrations tested on day 6.
Based on this observation, and in light of experience with the substance it was decided to apply a precautionary labelling of Corrosive 1C to (2-hydroxypropyl)trimethylammonium 2-ethylhexanoate.
Non guideline study (1975) 75% solution of (2-hydroxypropyl)trimethylammonium 2-ethylhexanoate in ethyleneglycol was was tested for skin irritancy in Albino Rabbits. A single 24 h, occluded application of the test material to the skin of 6 rabbits produced minimal, barely perceptible erythema and no edema. Observation at 72 h was same.
Based on the results of an eye irritation study in rabbits, Hydroxypropyl, N-2-, N,N,N-trimethylammonium 2-ethylhexanoate 75% in Ethyleneglycol is a primary ocular irritant.
Based on the results of an OECD 437 study (BCOP), is considered to be a moderate eye irritant.
However, based on observed skin corrosiveness and irritancy, and industrial experience, the substance must be considered as severly irritating to the eye, with the potential to cause severe eye damage.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation / corrosion, other
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2017
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Results of OECD 429 (LLNA) pre-test indicating corrosivity
- Justification for type of information:
- The OECD 429 (LLNA) test guideline states that
“Dose and vehicle selection should be based on the recommendations given in references (3) and (5). Consecutive doses are normally selected from an appropriate concentration series such as 100%, 50%, 25%, 10%, 5%, 2.5%, 1%, 0.5%, etc. Adequate scientific rationale should accompany the selection of the concentration series used. All existing toxicological information (e.g. acute toxicity and dermal irritation) and structural and physicochemical information on the test substance of interest (and/or structurally related test substances) should be considered where available, in selecting the three consecutive concentrations so that the highest concentration maximises exposure while avoiding systemic toxicity and/or excessive local skinirritation(3)(25).”
.” Excessive local skin irritation is indicated by an erythema score ≥3 and/or an increase in ear thickness of≥25% on any day of measurement(26)(27). The highest dose selected for the main LLNA study will be the next lower dose in the pre-screen concentration series (see paragraph18)that does not induce systemic toxicity and/or excessive local skin irritation.”
Scores of =/> 3 were observed at concentrations 50, 25 and 10%
Ear swelling was greater than 25% in substance 1833500 at 25 and 50%
Body weight loss (>5%) was observed possibly indicative of systemic toxicity.
The main argument for not continuing with the main LLNA studies is the interpretation of the study director with regard to eschar formation at all concentrations tested on day 6.
The definition of corrosivity is not met formally “Corrosivity is defined as irreversible (14 days) damage of the epidermis and dermis following exposure to a substance up to 4 hours on skin”, because observation in the pretests ended on day 6 in the pretests.
However, the observations in the pretests are indicative of the substances being corrosive, which may well have an influence on the proliferation of lymphocytes which in turn would result in a false positive result.
Based on this observation, and in light of experience with the substance it was decided to apply a precautionary labelling of Corrosive 1C to (2-hydroxypropyl)trimethylammonium 2-ethylhexanoate. - Qualifier:
- according to guideline
- Guideline:
- other: OECD 429 Local Lymph Node Assay
- Deviations:
- not applicable
- Principles of method if other than guideline:
- LLNA Pretests (x4)
The maximum concentration of test item to be investigated in the LLNA is determined as the dose that can be uniformly applied to the dorsal surface of the ears of the mice and which does at the same time not cause excessive skin irritation or clinical signs of toxicity after three consecutive daily applications.
In the absence of suitable acute toxicity and dermal irritation data or if the information suggests that irritation and/or toxicity is possible, a preliminary screening test will be conducted.
One animal will be treated with the test item at the maximum concentration that is suitable for application to the dorsal surface of the ears and an additional animal will be treated with the next lower concentration of the concentration series mentioned above.
Alternatively, a lower concentration may be investigated first if information is available to suggest that higher concentrations would be irritant or toxic. The animals will be treated, as detailed in the main experiment procedures section, for three consecutive days (days 1, 2 and 3). Clinical signs of toxicity and/or irritation at the treatment sites will be recorded on days 1 to 6 and a score will be used to grade a possible erythema of the ear skin. Furthermore, prior to the first application of the test item (day 1), on day 3 and before sacrifice (day 6) the ear thickness will be determined using a micrometer. Additionally, for both animals, the ears will be punched after sacrifice (day 6) at the apical area using a biopsy punch (Ø 8 mm corresponding to 0.5 cm2 ) and will be immediately pooled per animal and weighed using an analytical balance. - GLP compliance:
- yes
- Species:
- mouse
- Strain:
- CBA
- Type of coverage:
- open
- Preparation of test site:
- other: Mice were treated by (epidermal) topical application to the dorsal surface of each ear
- Vehicle:
- not specified
- Controls:
- not required
- Amount / concentration applied:
- 0.25% - 50%
- Duration of treatment / exposure:
- Animals were treated for three consecutive days (days 1, 2 and 3).
- Observation period:
- Animals sacrificed 3 days after final treatment (test duration 6 days)
- Number of animals:
- 2 animals per pretest. 4 pretests (8 animals total)
- Irritation parameter:
- other: eschar formation
- Basis:
- animal #1
- Time point:
- other: Day 6
- Reversibility:
- not reversible
- Remarks on result:
- other: Eshar formation and ear swelling indicating corrosion at 50% concentration of test substance
- Irritation parameter:
- other: eschar formation
- Basis:
- animal #2
- Time point:
- other: Day 6
- Reversibility:
- not reversible
- Remarks on result:
- other: Eshar formation and ear swelling indicating corrosion at 25% concentration of test substance
- Irritation parameter:
- other: eschar formation
- Basis:
- animal #3
- Time point:
- other: Day 6
- Reversibility:
- not reversible
- Remarks on result:
- other: Eshar formation and ear swelling indicating corrosion at 10% concentration of test substance
- Irritation parameter:
- other: eshar formation
- Basis:
- animal #4
- Time point:
- other: Day 6
- Reversibility:
- not reversible
- Remarks on result:
- other: Eshar formation and ear swelling indicating corrosion at 5% concentration of test substance
- Irritation parameter:
- other: eschar formation
- Basis:
- animal #5
- Time point:
- other: Day 6
- Reversibility:
- not reversible
- Remarks on result:
- other: Eshar formation and ear swelling indicating corrosion at 2.5% concentration of test substance
- Irritation parameter:
- other: eschar formation
- Basis:
- animal #6
- Time point:
- other: Day 6
- Reversibility:
- not reversible
- Remarks on result:
- other: Eshar formation and ear swelling indicating corrosion at 1% concentration of test substance
- Irritation parameter:
- other: ear lesions
- Basis:
- animal: 7
- Time point:
- other: Day 6
- Reversibility:
- not reversible
- Remarks on result:
- other: Eshar formation and ear swelling indicating corrosion at 0.5% concentration of test substance
- Irritation parameter:
- other: lesions
- Basis:
- animal: 8
- Time point:
- other: Day 6
- Reversibility:
- not reversible
- Remarks on result:
- other: Eshar formation and ear swelling indicating corrosion at 0.25% concentration of test substance
- Irritant / corrosive response data:
- The LLNA study was terminated after the fourth pre-test, since eschar formation was observed at all tested concentrations (see details in attached results). This is an indication for corrosive properties of the test item.
After 3 consecutive days of treatment animals showed visible ear swelling, evidence of hardened and scaly skin and lesions that progressed to eschar formation at sacrifice on day 6. - Interpretation of results:
- Category 1C (corrosive) based on GHS criteria
- Conclusions:
- The observations in the OECD 429 LLNA pretests are indicative of the substances being corrosive.
- Executive summary:
The OECD 429 (LLNA) test guideline states that:
“Dose and vehicle selection should be based on the recommendations given in references (3) and (5). Consecutive doses are normally selected from an appropriate concentration series such as 100%, 50%, 25%, 10%, 5%, 2.5%, 1%, 0.5%, etc. Adequate scientific rationale should accompany the selection of the concentration series used. All existing toxicological information (e.g. acute toxicity and dermal irritation) and structural and physicochemical information on the test substance of interest (and/or structurally related test substances) should be considered where available, in selecting the three consecutive concentrations so that the highest concentration maximises exposure while avoiding systemic toxicity and/or excessive local skinirritation(3)(25).”
.” Excessive local skin irritation is indicated by an erythema score ≥3 and/or an increase in ear thickness of≥25% on any day of measurement(26)(27). The highest dose selected for the main LLNA study will be the next lower dose in the pre-screen concentration series (see paragraph18)that does not induce systemic toxicity and/or excessive local skin irritation.”
Scores of =/> 3 were observed at concentrations 50, 25 and 10%
Ear swelling was greater than 25% in substance 1833500 at 25 and 50%
Body weight loss (>5%) was observed possibly indicative of systemic toxicity.
The main argument for not continuing with the main LLNA studies is the interpretation of the study director with regard to eschar formation at all concentrations tested on day 6.
The definition of corrosivity is not met formally “Corrosivity is defined as irreversible (14 days) damage of the epidermis and dermis following exposure to a substance up to 4 hours on skin”, because observation in the pretests ended on day 6 in the pretests.
However, the observations in the pretests are indicative of the substances being corrosive, which may well have an influence on the proliferation of lymphocytes which in turn would result in a false positive result.
Based on this observation, and in light of experience with the substance it was decided to apply a precautionary labelling of Corrosive 1C to (2-hydroxypropyl)trimethylammonium 2-ethylhexanoate.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other:
- Version / remarks:
- Section 1500.41. - Hazardous Substances and Articles , Administration and Enforcement Regulations, Federal Register, Vol . 38, No. 187, P. 27019, 27 September 1973.
- Principles of method if other than guideline:
- Sample was used as supplied. A group of six albino rabbits were clipped over a wide area. One side of the animals' backs was abraded at one side with
a lancet sufficiently deep t o penetrate the stratum corneum but not enter the derma to produce bleeding.
The skin of the other side was allowed to remain intact.
A 0.5 g portion o f material was applied to an abraded and an intact skin siteon the same rabbit. Gauze patches were then placed over the treated areas
and an impervious material was wrapped snugly around the trunks of the animals t o hold the patches in place. The wrapping was removed at the end of
the four hour period and the treated areas were examined. Readings were also made after twenty-four and seventy-two hours.
The Draize method o f scoring was employed. - GLP compliance:
- not specified
- Control samples:
- no
- Species:
- rabbit
- Strain:
- not specified
- Type of coverage:
- occlusive
- Preparation of test site:
- abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 g of 75% solution of (2-hydroxypropyl)trimethylammonium 2-ethylhexanoate in ethyleneglycol.
- Duration of treatment / exposure:
- 24 h
- Observation period:
- 24h/72h
- Number of animals:
- 6
- Details on study design:
- Sample was used as supplied. A group of six albino rabbits were clipped over a wide area. One side of the animals' backs was abraded at one side with
a lancet sufficiently deep t o penetrate the stratum corneum but not enter the derma to produce bleeding.
The skin of the other side was allowed to remain intact.
A 0.5 g portion o f material was applied to an abraded and an intact skin siteon the same rabbit. Gauze patches were then placed over the treated areas
and an impervious material was wrapped snugly around the trunks of the animals t o hold the patches in place. The wrapping was removed at the end of
the four hour period and the treated areas were examined. Readings were also made after twenty-four and seventy-two hours.
The Draize method o f scoring was employed. - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 7
- Reversibility:
- not specified
- Remarks on result:
- other: Intact Skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 7
- Reversibility:
- not specified
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.83
- Max. score:
- 7
- Reversibility:
- not specified
- Remarks on result:
- other: Abraded Skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 7
- Reversibility:
- not specified
- Remarks on result:
- other: Abraded Skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 7
- Reversibility:
- not specified
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 7
- Reversibility:
- not specified
- Remarks on result:
- other: Imtact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 7
- Reversibility:
- not specified
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 7
- Reversibility:
- not specified
- Remarks on result:
- other: Abraded skin
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- 75% solution of (2-hydroxypropyl)trimethylammonium 2-ethylhexanoate in ethyleneglycol was was tested for skin irritancy in Albino Rabbits.
A single 24 h, occluded application of the test material to the skin of 6 rabbits produced minimal, barely perceptible erythema and no edema. Observation at 72 h was same. - Executive summary:
75% solution of (2-hydroxypropyl)trimethylammonium 2-ethylhexanoate in ethyleneglycol was was tested for skin irritancy in Albino Rabbits. A single 24 h, occluded application of the test material to the skin of 6 rabbits produced minimal, barely perceptible erythema and no edema. Observation at 72 h was same.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other:
- Version / remarks:
- Section 173.240 (a) (1) Ti t l e 49 C F R
- Principles of method if other than guideline:
- Sample was used as supplied. A group of six albino rabbits were clipped over a wide area. One side of the animals' backs was abraded at one side with
a lancet sufficiently deep t o penetrate the stratum corneum but not enter the derma to produce bleeding.
The skin of the other side was allowed to remain intact.
A 0.5 g portion o f material was applied to an abraded and an intact skin siteon the same rabbit. Gauze patches were then placed over the treated areas
and an impervious material was wrapped snugly around the trunks of the animals t o hold the patches in place. The wrapping was removed at the end of
the four hour period and the treated areas were examined. Readings were also made after twenty-four and seventy-two hours.
The Draize method o f scoring was employed. - GLP compliance:
- not specified
- Control samples:
- no
- Species:
- rabbit
- Strain:
- not specified
- Type of coverage:
- occlusive
- Preparation of test site:
- abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 g of 75% solution of (2-hydroxypropyl)trimethylammonium 2-ethylhexanoate in ethyleneglycol.
- Duration of treatment / exposure:
- 4h
- Observation period:
- 4h/24h/72h
- Number of animals:
- 6
- Details on study design:
- Sample was used as supplied. A group of six albino rabbits were clipped over a wide area. One side of the animals' backs was abraded at one side with
a lancet sufficiently deep t o penetrate the stratum corneum but not enter the derma to produce bleeding.
The skin of the other side was allowed to remain intact.
A 0.5 g portion o f material was applied to an abraded and an intact skin siteon the same rabbit. Gauze patches were then placed over the treated areas
and an impervious material was wrapped snugly around the trunks of the animals t o hold the patches in place. The wrapping was removed at the end of
the four hour period and the treated areas were examined. Readings were also made after twenty-four and seventy-two hours.
The Draize method o f scoring was employed. - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 4 h
- Score:
- 0
- Max. score:
- 7
- Reversibility:
- not specified
- Remarks on result:
- other: Intact Skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.83
- Max. score:
- 7
- Reversibility:
- not specified
- Remarks on result:
- other: Intact Skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0.83
- Max. score:
- 7
- Reversibility:
- not specified
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 4 h
- Score:
- 0
- Max. score:
- 7
- Reversibility:
- not specified
- Remarks on result:
- other: Abraded Skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 7
- Reversibility:
- not specified
- Remarks on result:
- other: Abraded Skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 7
- Reversibility:
- not specified
- Remarks on result:
- other: Abraded Skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 4 h
- Score:
- 0
- Max. score:
- 7
- Reversibility:
- not specified
- Remarks on result:
- other: Intact Skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 7
- Reversibility:
- not specified
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 7
- Reversibility:
- not specified
- Remarks on result:
- other: Imtact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 4 h
- Score:
- 0
- Max. score:
- 7
- Reversibility:
- not specified
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 7
- Reversibility:
- not specified
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 7
- Reversibility:
- not specified
- Remarks on result:
- other: Abraded skin
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- 75% solution of (2-hydroxypropyl)trimethylammonium 2-ethylhexanoate in ethyleneglycol was was tested for skin irritancy in Albino Rabbits.
A single 4 h, occluded application of the test material to the skin of 6 rabbits produced no erythema or edema. 24 and 72 h observation showed minimal, barely perceptible erythema and no edema. - Executive summary:
75% solution of (2-hydroxypropyl)trimethylammonium 2-ethylhexanoate in ethyleneglycol was was tested for skin irritancy in Albino Rabbits. A single 4 h, occluded application of the test material to the skin of 6 rabbits produced no erythema or edema. 24 and 72 h observation showed minimal, barely perceptible erythema and no edema.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Solvent-free Dabco TMR Batch# meyersl.20160601
- Species:
- cattle
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- Three bovine corneas per group were dosed with 0.75 ml of Solvent-free Dabco TMR
- Duration of treatment / exposure:
- 10 minutes
- Duration of post- treatment incubation (in vitro):
- N/A
- Number of animals or in vitro replicates:
- Three bovine corneas per group
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 1
- Value:
- 34.12
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- 1
- Value:
- 15.67
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- other: Corrected Mean Optical Density
- Run / experiment:
- 1
- Value:
- 1.23
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- Category 2B (mildly irritating to eyes) based on GHS criteria
- Conclusions:
- Based on an In Vitro Irritatancy Score between 3 and 55, no prediction can be made for the UN GHS
categorization of the test article as defined in OECD Guideline #437.
According to EURL ECVAM DB-ALM Protocol No. 127, Solvent-free Dabco TMR Batch# meyersl.20160601 is considered to be a moderate eye irritant. - Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April-June 1975
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Qualifier:
- according to guideline
- Guideline:
- other: Sect ion 1500.42, - Hazardous Substances and Articles , Administration and Enforcement Regulations, Federal Register, Vol. 38, No. 187, P. 27019, 27 September 1973. .
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- The sample was used as supplied.
- Species:
- rabbit
- Strain:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.1 ml of 75% solution of (2-hydroxypropyl)trimethylammonium 2-ethylhexanoate in ethyleneglycol.
- Duration of treatment / exposure:
- The test material was not washed from the eyes.
- Observation period (in vivo):
- 1,24,48 & 72 hrs. and 5 & 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- Six healthy young adult albino rabbits were used in th i s study. 0.1 gm o f the experimental material was instilled into the right eyes of the test
animals while the other eyes remained untreated t o serve as controls. The test material was not washed from the eyes.
The treated eyes were examined at 1,24,48 & 72 hrs. and 5 & 7 days following. instillation of the test material into the eyes. Interpretation o f the
results was made i n accordance with the grading system outlined in the "Illustrated Guide for Grading Eye lrritation By Hazardous Substances". - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- >= 6 - <= 8
- Max. score:
- 8
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- >= 4 - <= 6
- Max. score:
- 6
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- >= 4 - <= 6
- Max. score:
- 6
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 5
- Max. score:
- 5
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 5
- Max. score:
- 5
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 5
- Max. score:
- 5
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 30
- Max. score:
- 30
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 30
- Max. score:
- 30
- Reversibility:
- not specified
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Based on these results, Hydroxypropyl, N-2-, N,N,N-trimethylammonium 2-ethylhexanoate 75% in Ethyleneglycol is a primary ocular irritant.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
Justification for classification or non-classification
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