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EC number: 205-619-1 | CAS number: 144-19-4
- 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
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2,2,4-trimethylpentane-1,3-diol
- EC Number:
- 205-619-1
- EC Name:
- 2,2,4-trimethylpentane-1,3-diol
- Cas Number:
- 144-19-4
- Molecular formula:
- C8H18O2
- IUPAC Name:
- 2,2,4-trimethylpentane-1,3-diol
- Details on test material:
- The test material, E 2932.01 (TMPD), a white powder, was received on August 1, 1986 and was stored at ambient temperature.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Nine (9) New Sealand White strain rabbits in the weight range 2.4 to 3.5 kg, prior to treatment on day 1 and approximately 11 to 15 weeks of age were obtained from Froxfield Rabbits, Petersfield, Hampshire, England. The rabbits selected for the study were all acclimated to the laboratory environment.
Each animal was identified by a numbered aluminum tag placed through the edge of one ear. This number was unique within the HRC Industrial toxicology Department throughtout the duration of the study. The rabbits were individually housed in metal cages with performated floors in Building R 14, Room 2. They had free access to tap water and SDS Standard Rabbit Diet.
Animal room temperature was maintained at approximately 19 degrees C and relative humidity at 30-70%. Air exchanges was maintained at approximately 19 air changes per hour and lighting was controlled to give 12 hours of artificial light in each 24-hour period.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 4.5mg of test material was applied to each treated eye
- Duration of treatment / exposure:
- one single administration
- Observation period (in vivo):
- 21 days post-exposure
- Number of animals or in vitro replicates:
- nine (9)
- Details on study design:
- Rabbits were allocated to two treatment groups. For group 1, a total of six rabbits were used, wherein E 2932.01 (4.5mg) was applied directly to the corneal surface of one eye of each animal, and the eyelids were immediately released. The test material was allowed to remain for the duration of the study. The contralateral eye remained untreated and served as a control.
For group 2, a total of three rabbits were used, wherein 4.5mg of E 2932.01 was applied directly to to corneal surface of one eye of each animal. Approximately 4 seconds after instillation of the test material the treated eyes were rinsed using 20 mL of lukewarm tap water.
OBSERVATIONS AND SCORING
Examination of the eyes were made 1, 2, 3, 4, and 7 days after instillation. Observation of the eyes was aided by the use of a handheld torch.
Grading and scoring of the ocular lesions were performed based on a Numerical scoring system as described by Draize (1959).
MAXIMUM AVERAGE SCORE
The total score for the eye (P&G score) is the sum of all the scores obtained for the cornea, iris and conjunctivae. The maximum average score (MAS) was calculated by averaging the highest total P&G score on any one day.
MEDIAN RECOVERY TIME
The median number of days for the eyes to clear was calculated by placing the animals in sequential order with regard to persistence of the response to treatment. Teh average number opf days of the eyes of the third and fourth animal in the series to become normal was then calculated to the nearest 0.1 day.
CLASSIFICATION
The test substance is considered to be non-irritant when no corneal damage, on iridial inflammation or conjuctival grades in excess of 1 are observed at the 24 hour reading.
A slight irritant is characterized by any of the following changes at the 24 hour or subsequent readings, which clear by day 7:
opacity of cornea (other than a slight dulling)
iridial inflammation
conjunctival grades 2 and above
conjunctival grades of 1 persisting beyond 24 hours
A moderate irritant is characterized by changes/lesions in the ocular tissues persisting beyond 7 days but clearing by day 21.
A severe irritant is a test substance that produces reactions persisting beyond ay 21 or that produces a necrotic lesion.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Remarks:
- group 1
- Basis:
- mean
- Time point:
- other: 24 hour
- Score:
- 7
- Max. score:
- 110
- Reversibility:
- fully reversible
- Irritation parameter:
- overall irritation score
- Remarks:
- group 1
- Basis:
- mean
- Time point:
- other: 48 hour
- Score:
- 5
- Max. score:
- 110
- Reversibility:
- fully reversible
- Irritation parameter:
- overall irritation score
- Remarks:
- group 1
- Basis:
- mean
- Time point:
- other: 72 hour
- Score:
- 3
- Max. score:
- 110
- Reversibility:
- fully reversible
- Irritation parameter:
- overall irritation score
- Remarks:
- group 1
- Basis:
- mean
- Time point:
- other: 4 days
- Score:
- 1
- Max. score:
- 110
- Reversibility:
- fully reversible
- Irritation parameter:
- overall irritation score
- Remarks:
- group 1
- Basis:
- mean
- Time point:
- other: 7 days
- Score:
- 0
- Max. score:
- 110
- Reversibility:
- fully reversible
- Irritation parameter:
- overall irritation score
- Remarks:
- group 2
- Basis:
- mean
- Time point:
- other: 24 hour
- Score:
- 2
- Max. score:
- 110
- Reversibility:
- fully reversible
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 48 hour
- Score:
- 0
- Max. score:
- 110
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- other: Average score calculated
- Remarks:
- average score calculated
- Time point:
- 7 d
- Score:
- 7
- Max. score:
- 110
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 7
- Max. score:
- 110
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 7
- Max. score:
- 110
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- other:
- Time point:
- 7 d
- Score:
- 7
- Max. score:
- 110
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 2
- Max. score:
- 110
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- rinse after 4 sec
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 2
- Max. score:
- 110
- Reversibility:
- not fully reversible within: mild conjuction was seen
- Remarks:
- mild conjuction was seen
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 2
- Max. score:
- 110
- Reversibility:
- fully reversible
- Remarks:
- rinse after 4 sec
- Remarks on result:
- no indication of irritation
- Remarks:
- rinse after 4 sec
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 2
- Max. score:
- 110
- Reversibility:
- fully reversible
- Remarks:
- rinse after 4 sec
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Group 1 (no rinse)
Corneal opacity developed in one animal. Transient iritis was seen in one animal. A diffuse crimson red colorization was seen in two animals ans was accompanied in one by considerable swelling with partial eversion of the eyelids. Mild conjuctival reactions were observed in two animals. Two animals did not show any observable response to treatment throughout the observation period. The MAS and median recovery time were calculated to be 7 and 2.5 days, respectively.
Group 2 (rinsed)
No corneal damage or iridial inflammation was seen in ay of the animals. Transient mild conjuctival reactions were observed in two animals. One animal did not show any observable response to treatment throughout the observation period. The MAS was calculated to be 2.
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- E 2932.01 (TMPD) is considered to be a slight irritant
- Executive summary:
The test material (TMPD) was instilled in one eye of 9 rabbits; in 6 rabbits (group 1), the test material was not disturbed following treatment, while in 3 rabbits (group 2), the treated eye was rinsed with tap water approximately 4 seconds after instillation. For rabbits in Group 1, Corneal opacity developed in one animal. Transient iritis was seen in one animal. A diffuse crimson red colorization was seen in two animals ans was accompanied in one by considerable swelling with partial eversion of the eyelids. Mild conjuctival reactions were observed in two animals. Two animals did not show any observable response to treatment throughout the observation period. The maximum average score (MAS) and median recovery time were calculated to be 7 and 2.5 days, respectively. For rabbits in Group 2, no corneal damage or iridial inflammation was seen in ay of the animals. Transient mild conjuctival reactions were observed in two animals. One animal did not show any observable response to treatment throughout the observation period. The MAS was calculated to be 2. For both groups, the highest MAS was observed at 24 hours after treatment, and all findings were fully reversible during the observation period. From these data, TMPD is considered to be a slight irritant.
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