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EC number: 230-991-7 | CAS number: 7397-62-8
- 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:
- 1988-JAN-19 through 1988-JAN-26
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Butyl glycollate
- EC Number:
- 230-991-7
- EC Name:
- Butyl glycollate
- Cas Number:
- 7397-62-8
- Molecular formula:
- C6H12O3
- IUPAC Name:
- butyl glycolate
- Reference substance name:
- Polysolvan O
- IUPAC Name:
- Polysolvan O
- Reference substance name:
- Glycolic acid-n-butyl ester
- IUPAC Name:
- Glycolic acid-n-butyl ester
- Details on test material:
- - Name of test material (as cited in study report): Polysolvan O (butyl glycollate)
- Physical state: liquid
- Analytical purity: 96%
- Impurities (identity and concentrations): chloro acetic acid n-butyl ester (% not stated), butoxy acetic acid n-butylester
- Purity test date: 04.01.1988
- Lot/batch No.: batch from 29.12.1987
- Storage condition of test material: in the dark at 22°C
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AK, Kastengrund, Germany
- Age at study initiation: about 3 – 5 months
- Weight at study initiation: 2.1 – 2.9 kg
- Housing: single in cages
- Diet (e.g. ad libitum): standard chow (Altromin 2123 Haltungsdiaet Kaninchen, Altromin GmbH, Lage/Lippe, Germany) ad libitum
- Water (e.g. ad libitum): tap water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 50 ± 20%
- Photoperiod (hrs dark / hrs light): 12 Hrs light/12 hrs dark
IN-LIFE DATES: From: 1988-Jan-19 to 1988-Jan 26
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): neat
VEHICLE
- none - Duration of treatment / exposure:
- 4 h
- Observation period:
- 30 - 60 minutes, 24, 48 and 72 hours, day 7
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 × 2.5 cm
- Type of wrap if used: gauze patches were secured with adhesive tape and loosely fixed, semi-occlusive
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with lukewarm water at the end of the 4 h exposure period
- Time after start of exposure: 4 h
SCORING SYSTEM: according to the OECD 404 procedure (method of Draize)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 30 - 60 min
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0.66
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 30 - 60 min
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- Overall irritation score (24, 48 and 72 h):
Erythema: 0.2 (all animals)
Edema: 0.1 (all animals)
Any other information on results incl. tables
Individual results:
Time after patch removal |
30 – 60 min |
24 h |
48 h |
72 h |
7 d |
||||||||||
Animal No. |
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
Edema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Polysolvan O (butyl glycollate, 96%) was examined for its skin irritating potential in a valid study conducted according to OECD test guideline No. 404 and under GLP conditions. The test substance was not irritating to the rabbit’s skin.
- Executive summary:
In a primary dermal irritation study, 3 young adult white rabbits were dermally exposed to 0.5 mL of unchanged Polysolvan O (butyl glycollate, 96 %) for 4 hours under semi-occlusive condition. The animals were observed for up to 7 days. Irritation was scored according to the method of Draize (cf. OECD TG 404).
Erythema and edema were not seen at the 30 - 60 min, 24 and 48 h readings. At 72 h only 1/3 rabbits revealed a transient erythema and edema (grade 2 and 1, respectively), which disappeared until day 7. Thus, Polysolvan O (butyl glycollate, 96 %) was not a dermal irritant.
CONCLUSION
Polysolvan O (butyl glycollate, 96 %) was examined for its skin irritating potential in a valid study conducted according to OECD test guideline No. 404 and under GLP conditions. The test substance was not irritating to the rabbit’s skin.
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