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EC number: 224-709-1 | CAS number: 4457-71-0
- 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
In two in vivo skin irritation studies in rabbits, MPD was found to be non-irritant.
In an in vivo eye irritation study in rabbits (GLP and OECD TG 405) MPD was considered non-irritating. A supporting in vivo eye study in rabbits (no GLP and similar to OECD TG 405) reported MPD as being irritating with effects that were not reversed after 7 days.
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:
- 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to an appropriate OECD test method.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): 3-Methyl-1,5 pentanediol
- Physical state: clear, colorless liquid
- test substance recieved on (date): 1 July 1987
- Sample designation: 3-Methyl-1,5-pentanediol
- Purity: > 99%
- Stability under test conditions: the stability and absorption of the test substance were not determined
- Storage condition of test material: at ambient temperature
- Other: the test substance was administered as supplied by the sponsor - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: three New Zealand White rabbits (from Buckmaster, Henham, Hertfordshire, England)
- Age at study initiation: approx. 9 to 10 weeks
- Weight at study initiation: approx. 2.0 to 2.3 kg prior to treatment
- Housing: individually housed in metal cages
- Diet (e.g. ad libitum): SDS Standard Rabbit Diet
- Water (e.g. ad libitum): tap water
- Acclimation period: acclimated to the laboratory environment
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19°C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 19 per hr
- Photoperiod (hrs dark / hrs light): 12 hr light/ 12 hr dark - Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 ml aliquot of 3-methyl-1,5-pentanediol
- Duration of treatment / exposure:
- 4 hr
- Observation period:
- Examination of the treated skin was made on day 1 (approx. 30 minutes after removal of the patches), 2, 3 and 4.
- Number of animals:
- 3
- Details on study design:
- Rabbits were dosed with 0.5 ml of the test substance. The dose was applied under a 2.5 cm square gauze pad to a clipped, intact skin site of each animal. Each treatment site was occulded with "Elastoplast" elastic adhesive dressing for a four hour period. At the end of the exposure period, the semi-occulsive dressing and gauze pad were removed and the treatment site was washed using water to remove any residual test substance.
Examination of the treated skin was made on day 1 (approx. 30 minutes after removal of the patches) and on days 2, 3, and 4
Grading and scoring of the dermal reactions were performed using the prescribed numerical scoring system as follows:
Erythema and eschar formation:
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries 4
in depth)
Oedema formation:
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well-defined by definite raising) 2
Moderate oedema (raised approximately 1 millimetre) 3
Severe oedema (raised more than 1 millimetre and extending 4
beyond the area of exposure)
Interpretation of results and classification of substance
The results obtained were evaluated taking into consideration the nature and the reversibility or irreversibility of the findings observed. Classification of the substance is based on the criteria laid down in: Regulation 1272/2008 EC, Annex I, table 3.2.2 - Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: see Remarks
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: see Remarks
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: see Remarks
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hr
- Remarks on result:
- other:
- Remarks:
- first reading taken approx 30 mins after removal of dressing
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: see Remarks
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: see Remarks
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hr
- Remarks on result:
- other:
- Remarks:
- first reading taken approx 30 mins after removal of dressing
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: see Remarks
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: see Remarks
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24hr
- Remarks on result:
- other:
- Remarks:
- first reading taken approx 30 mins after removal of dressing
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: see Remarks
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: see Remarks
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions described in this study report, 3-methyl-1,5-pentanediol was considered as non-irritant when applied to the skin of rabbits.
Reference
Very slight erythema was observed in all three animals on Day 1. The reactions had resolved by Day 2.
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:
- supporting study
- Study period:
- 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions (limited documentation, 0.05 mL application amount, 8 day observation period)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- (limited documentation, 0.05 mL application amount, 8 day observation period)
- GLP compliance:
- no
- Specific details on test material used for the study:
- - Name of test substance (as cited in study report): 3-Methylpentanodiol-1,5
- Analytical purity: 99.5%
- Physical state: liquid
- Density: 0.973 g/mL - Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: 3.27 and 2.77 kg (first experiment); 3.45 kg and 3.43 kg (second experiment)
no additional details reported - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: other eye of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.05 mL
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- one single application
- Observation period (in vivo):
- 8 days
- Readings, first experiment: 10 min; 1, 3, 24 and 72 h, day 6 and 8
- Readings, second experiment: 10 min; 1, 3, 24, 48 and 72 h; day 4, 7 and 8 - Number of animals or in vitro replicates:
- 4 males (2 in each experiment)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: evaluation was performed according to the Draize Scoring System
TOOL USED TO ASSESS SCORE: fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- (out of animal#3 and #4)
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Interpretation of results:
- Category 2A (irritating to eyes) based on GHS criteria
- Conclusions:
- Based on the results of this study classification for eye irritation is warranted as follows:
CLP: Category 2
GHS (UN): Category 2A
Reference
Table 1: Eye irritation: Details on result
Exp. 1 |
||||||||
Reading |
Animal#1 |
Animal#2 |
||||||
Cornea |
Chemosis |
Iris |
Conjunctivae |
Cornea |
Chemosis |
Iris |
Conjunctivae |
|
10 min |
0 |
1 SD |
0 |
1 |
0 |
1 SD |
0 |
1 |
1 h |
0 |
2 SD |
0 |
1 |
0 |
2 SD |
0 |
1 |
3 h |
0 |
2 SD |
0 |
1 |
1 |
1 SD |
0 |
1 |
24 h |
1 |
2 SD |
0 |
2 |
1 |
1 SD |
0 |
2 |
72 h |
1 |
0 SD |
0 |
1 |
1 |
0 SD |
0 |
1 |
Day 6 |
0 |
0 |
0 |
1 |
1 SC |
0 |
0 |
1 |
Day 8 |
0 |
0 |
0 |
0 |
1 SC |
0 |
0 |
1 |
Mean (24 – 72 h) |
1.0 |
1.0 |
0.0 |
1.5 |
1.0 |
0.5 |
0.0 |
1.5 |
Mean (animal #1 and 2) |
1.0 |
0.75 |
0.0 |
1.5 |
|
|||
Exp. 2 |
||||||||
Reading |
Animal#3 |
Animal#4 |
||||||
Cornea |
Chemosis |
Iris |
Conjunctivae |
Cornea |
Chemosis |
Iris |
Conjunctivae |
|
10 min |
0 |
1 SD |
0 |
1 |
0 |
1 SD |
0 |
1 |
1 h |
0 |
2 S |
0 |
1 |
0 |
1 S |
0 |
1 |
3 h |
1 |
2 SD |
0 |
1 |
1 |
1 SD |
0 |
1 |
24 h |
1 |
2 S |
1 |
2 |
1 |
1 S |
1 |
1 |
48 h |
2 |
1 SD |
0 |
2 |
2 |
1 SD |
0 |
2 |
72 h |
2 |
1 SD |
0 |
2 |
2 |
1 SD |
2 |
2 |
Day 4 |
2 SC |
0 |
0 |
2 |
2 |
1 SD |
2 |
2 |
Day 7 |
1 SC |
0 |
0 |
1 |
2 SC |
0 |
0 |
1 |
Day 8 |
1 SC |
0 |
0 |
1 |
1 SC |
0 |
0 |
1 |
Mean (24 – 72 h) |
1.67 |
1.33 |
0.33 |
2.00 |
1.67 |
1.00 |
1.00 |
1.67 |
Mean (animal #3 and 4) |
1.67 |
1.17 |
0.67 |
1.84 |
|
SD = smeary deposit; S = secretion; scar formation
Evaluation was performed based on the results with animal#3 and animal#4 (experiment 2), because scoring was performed at all relevant time points and the reactions were stronger than with animal#1 and 2. Scar formation was not considered, because sight was not affected.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
There are no reports of human eye, skin or respiratory irritation associated with MPD exposure. MPD has been tested on animals and the results demonstrate that this substance is not a acute skin irritant (Huntingdon (1987), 871011D).
Skin irritation
Semiocclusive application of MPD (Michael P. Liggett; Paul A. Smith (1987)) on 3 New Zealand White Rabbits for 4 hours (according to OECD TG 404) resulted in erythema score of 1/4 on day 1 (approximately 30 min after removal of the dressing) and 0/4 on day 2, 3, and 4. day 1. The very slight erythema observed in all three animals on Day 1 resolved by day 2. An edema score of 0/4 were observed on day 1, 2, 3 and 4. In a supporting study (BASF AG (1976)) according to OECD TG 404 similar results were observed.
Eye irritation
MPD was tested (Michael P. Liggett; Paul A. Smith (1987)) in the key in vivo test in rabbits (according to OECD TG 405 and GLP). The mean score for cornea opacity was above 1.0 for one rabbit and the mean score for iris and conjunctivae redness/chemosis was lower than 1 or 2, respectively on day 1, 2 and 3. Corneal opacity and conjunctivae redness and chemosis were fully reversible within 7 days.
In a supporting in vivo test (Dr. med Hofmann; Dr. rer. nat. Munk (1976)) with rabbits (similar to OECD TG 405 and non GLP), the mean score for cornea opacity was above 1.0 and not fully reversible within the observation period of 8 days and the score for iris for one animal was 1 and fully reversible within 7 days. The score for one animal for conjunctivae redness was 2 and not fully reversible whithin the observation period of 8 days. The result of the supporting study demonstrates that the substance is eye irritant.
Justification for classification or non-classification
Based on the current data-set, the registered substance is not classified for adverse effects on the skin. The regsitered substance is classified as an Eye irritant (Cat. 2) following 1272/2008/EC and 67/578/EEC.
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