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EC number: 203-951-1 | CAS number: 112-25-4
- 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
Endpoint summary
Administrative data
Description of key information
Several non-GLP studies according to or equivalent to OECD guidelines 404 and 405 are available. In addition, a in vitro skin corrosion study is available.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards, well documented and acceptable for assessment.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)
- Principles of method if other than guideline:
- - OECD Guideline for testing of chemicals, draft proposal for a new guideline: "In vitro Skin Corrosion tests", Draft November 1999.
- GLP compliance:
- yes (incl. QA statement)
- Species:
- other: EpiDerm (reconstructed three dimensional human epidermis model)
- Strain:
- other: EpiDerm (reconstructed three dimensional human epidermis model)
- Details on test animals or test system and environmental conditions:
- - Tissue model: Epi-200
- Source: MatTek Corporation, Ashland MA, USA - Type of coverage:
- other: not applicable
- Preparation of test site:
- other: not applicable
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Negative control (NC): Doubly distilled water; Positive control (PC): 8 n potassium hydroxyde (Sigma-Aldrich, Munich, Germany); MTT-reduction control (KC): Doubly distilled water or test substance
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 50 µl
- Concentration: undiluted - Duration of treatment / exposure:
- 3 min and 1 h
- Number of animals:
- 2 EpiDerm tissues per time point
- Details on study design:
- Test Conditions:
- The potential of the test substance to cause dermal corrosion was assessed by a single topical application of 50 µl of the test substance to a reconstructed three dimensional human epidermis model (EpiDerm). Duplicates of the EpiDerm tissue were incubated with the test substance for 3 min and 1 h, followed by a colorimetric determination of the possibly induced cytotoxic effect.
- Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity, measured by reduced formazan production after incubation with a tetrazolium salt. The formazan production of the test substance treated epidermal tissues is compared to the negative control tissues, calculated as relative tissue viability.
- Evaluation criteria:
mean tissue viability (% negative control) => prediction
3 min: < 50 => corrosive
3 min: >= 50 and 1 hour < 20 => corrosive
3 min: >= 50 and 1 hour: >= 20 => non-corrosive - Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 min
- Value:
- 94
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: The test substance is able to directly reduce MTT. However, this ability of direct MTT reduction did not impair the study result as demonstrated by the concurrently performed exposure of freeze-killed control tissues.
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1 hour
- Value:
- 9
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: The test substance is able to directly reduce MTT. However, this ability of direct MTT reduction did not impair the study result as demonstrated by the concurrently performed exposure of freeze-killed control tissues.
- Other effects / acceptance of results:
- Viability of the test substance treated tissues determined after an exposure period of 3 minutes was 94 % and for the exposure period 1 hour 9 %. The test substance is able to directly reduce MTT. However, this ability of direct MTT reduction did not impair the study result as demonstrated by the concurrently performed exposure of freeze-killed control tissues.
Conclusion: The test substance has a corrosive potential in the EpiDerm skin corrosivity test (OECD GHS category 1B). - Interpretation of results:
- Category 1B (corrosive) based on GHS criteria
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The test substance has a corrosive potential in the EpiDerm skin corrosivity test
- Executive summary:
The study meets generally accepted scientific standards, is well documented and acceptable for assessment. It was conducted in accordance to a draft proposal for a new OECD guideline: "In vitro Skin Corrosion tests" (Draft November 1999).
The potential of the test substance to cause dermal corrosion was assessed by a single topical application of 50 µl of the test substance to a reconstructed three dimensional human epidermis model (EpiDerm). Duplicates of the EpiDerm tissue were incubated with the test substance for 3 minutes and 1 hour, followed by a colorimetric determination of the possibly induced cytotoxic effect. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity, measured by reduced formazan production after incubation with a tetrazolium salt (MTT assay). The formazan production of the test substance treated epidermal tissues is compared to the negative control tissues, calculated as relative tissue viability.
Viability of the test substance treated tissues determined after an exposure period of 3 minutes was 94 % and for the exposure period 1 hour 9 %. The test substance is able to directly reduce MTT. However, this ability of direct MTT reduction did not impair the study result as demonstrated by the concurrently performed exposure of freeze-killed control tissues.
Conclusion: The test substance has a corrosive potential in the EpiDerm skin corrosivity test (OECD GHS category 1B).
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study was conducted in accordance with GLP and as per DOT and IATA guideline.
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- other: DOT Appendix A HMR HM-215A 173.1300 IATA Resolution 618, Attachment A, 3.8.2
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hare-Marland, Inc. Hewitt, New Jersey
- Weight at study initiation: 2.0 to 2.3 kg
- Housing: Individually housed in suspended, stainless steel cages with wire mash bottoms
- Diet (ad libitum): Certified Lab Rabbit diet HF, No. 5325
- Water (ad libitum): Municipal water
- Acclimation period: 18 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Standard conditions
- Humidity (%): Standard conditions
- Air changes (per hr): Standard conditions
- Photoperiod: (12 hrs dark / 12 hrs light)
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- - Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): pure substance (100%) - Duration of treatment / exposure:
- A single administration at three separate sites. The exposure period at the three sites was 3 minutes, 60 minutes or 4 hours, followed by a 14-day observation period.
- Observation period:
- 14 days
- Number of animals:
- 6 animals ( 4 males and 2 females )
- Details on study design:
- TEST SITE- 0.5 ml of test material was applied directly on the test sites and covered with gauze square, 1” by 1”, which was held in place with tape. Impervious plastic was then wrapped around the animal and secured with the tape to keep the test material in contact with the skin. Elizabethan collars were placed on the animals prior to dosing to prevent disruption of the wrappings and ingestion of the test material.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Test site was washed with 0.9 % saline
- Time after start of exposure: 4h
- SCORING SYSTEM: skin reaction is scored by the method of Draize (see table below) - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: desquamation observed from day 7 to end of study
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: desquamation observed from day 7 to end of study
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: desquamation observed from day 7 to end of study
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: desquamation observed from day 7 to end of study
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: sub epidermal tissue damage observed. Eschar formation.
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: desquamation observed from day 7 to end of study
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritant / corrosive response data:
- Immediately following a 3-minutes exposure, all six animals were free of skin irritation. Subsequently, two animals exhibited moderate erythema with very slight or slight edema and four animals exhibited slight erythema with little or no edema. By 7 days post-dose, one animal exhibited subepidermal tissue damage with eschar, which persisted to study termination (14 days post-dose). The irritation of the remaining animals subsided to slight erythema in one animal or no irritation in four animals. There was evidence of irreversible alteration of the tissue at one of the six 3- minute exposure sites.
Immediately after a 60-minute exposure, three of the six animals exhibited moderate erythema with very slight edema; the remaining three animals had only very slight (barely perceptible) erythema without edema. Within 24 hours, three animals exhibited subepidermal tissue damage, which persisted with eschar and scarring to 14 days post-dose. Within 72 hours, one additional animal exhibited subepidermal tissue damage, which persisted with eschar to 7 days post-dose; and another animal exhibited superficial tissue damage, which persisted with eschar to 14 days post-dose. The remaining animal was free of all skin irritation by study termination (14 days post-dose). There was evidence of irreversible alteration of the tissue at 3 of the six 60-minutes exposure sites.
Immediately after a 4-hour exposure, five of the six animals exhibited super ficial or subepidermal tissue damage, which persisted with eschar and scarring to 14 days post-dose. The remaining animal had only moderate erythema with edema immediately after the 4-hour exposure but exhibited subepidermal damage within 24 hours post-dose, - Other effects:
- None
- Interpretation of results:
- Category 1B (corrosive) based on GHS criteria
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- In conclusion, Ethylene glycol mono hexyl ether (hexyl CELLOSOLVE), under conditions of this study, produced generally mild to moderate reversible skin irritation after a 3-minute exposure; however, severe irreversible alteration of the skin was evident in one of the six animals after a 3-minute exposure. There was irreversible alteration of the skin o f three of the six animals after a 60-minute exposure; and irreversible alteration of the skin of all six animals after a 4-hour exposure. Therefore, Hexyl Cellosolve Solvent would be classified as follows: "Class 8 Dangerous Goods, Packing Group 11,” according to DOT criteria.
- Executive summary:
Ethylene glycol mono hexyl ether (hexyl CELLOSOLVE) was evaluated for acute skin irritation test in rabbits. The hair of six new Zealand White rabbits was closely clipped to expose the back. One half of a milligliter (0.5 mL) of the test material was applied, as received, beneath a 6 cm2 gauze square, placed directly on three intact test sites per animal. These sites were occluded during the 3-minutes, 60-minutes and 4-hour exposure periods (one site/exposure period). At the end of each exposure period, the appropriate patch was removed and the site was evaluated for skin irritation. The site was then wiped free of test material. Observations for skin irritation were made again at 24, 48 and 72 hours and 7 and 14 days after test material administration.
Immediately following a 3-minutes exposure, all six animals were free of skin irritation. Subsequently, two animals exhibited moderate erythema with very slight or slight edema and four animals exhibited slight erythema with little or no edema. By 7 days post-dose, one animal exhibited subepidermal tissue damage with eschar, which persisted to study termination (14 days post-dose). The irritation of the remaining animals subsided to slight erythema in one animal or no irritation in four animals. There was evidence of irreversible alteration of the tissue at one of the six 3- minute exposure sites.
Immediately after a 60-minute exposure, three of the six animals exhibited moderate erythema with very slight edema; the remaining three animals had only very slight (barely perceptible) erythema without edema. Within 24 hours, three animals exhibited subepidermal tissue damage, which persisted with eschar and scarring to 14 days post-dose. Within 72 hours, one additional animal exhibited subepidermal tissue damage, which persisted with eschar to 7 days post-dose; and another animal exhibited superficial tissue damage, which persisted with eschar to 14 days post-dose. The remaining animal was free of all skin irritation by study termination (14 days post-dose). There was evidence of irreversible alteration of the tissue at 3 of the six 60-minutes exposure sites.
Immediately after a 4-hour exposure, five of the six animals exhibited super ficial or subepidermal tissue damage, which persisted with eschar and scarring to 14 days post-dose. The remaining animal had only moderate erythema with edema immediately after the 4-hour exposure but exhibited subepidermal damage within 24 hours post-dose,
In conclusion, Hexyl Cellosolve Solvent, under conditions of this study, produced generally mild to moderate reversible skin irritation after a 3-minute exposure; however, severe irreversible alteration of the skin was evident in one of the six animals after a 3-minute exposure. There was irreversible alteration of the skin of three of the six animals after a 60-minute exposure; and irreversible alteration of the skin of all six animals after a 4-hour exposure. Therefore, Hexyl Cellosolve Solvent would be classified as follows: "Class 8 Dangerous Goods, Packing Group 11,” according to DOT criteria.
Referenceopen allclose all
- Viability of the test substance treated EpiDerm tissues determined after an exposure period of 3 min was 94% and for the exposure period 1 h 9%.
- The test substance is able to directly reduce MTT. However, this ability of direct MTT reduction did not impair the study result as demonstrated by the concurrently performed exposure of freeze-killed control tissues.
See the Attachment-1 for tables:
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP study according to OECD guideline 405 (acute eye irritation/corrosion) study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Firma Gaukler, Offenbach/Main
- Weight at study initiation: mean value males: 2,62 kg; mean value females: 2.67 kg
- Housing: individual, stainless steel wire mesh cages
- Diet: Ovator Solikanin 4 mm, Muskator-Werke, Düsseldorf, ca. 130 g/day
- Water: tap water ca. 250 ml/day
- Acclimation period: at least 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 ml
- Concentration: undiluted - Duration of treatment / exposure:
- unwashed (21 d)
- Observation period (in vivo):
- 21 d
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
SCORING SYSTEM:
Criteria for assessment of ocular lesions:
Cornea*: opacity (op): Degree of density (area most dense taken for reading)
0 = No ulceration or opacity.
1 = Scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible.
2 = Easily discernible translucent area, details of iris slightly obscured.
3 = Nacreous area, na details of iris visible, size of pupil barely discernible.
4 = Opaque cornea, iris not discernible through the opacity.
Area of cornea involved (ar):
1 ≥ 0 ; ≤ ¼
2 ≥ ¼ ; < ½
3 ≥ ½; < ¾
4 ≥ ¾
Conjunctivae*
redness (red): (Refers to palpebral and bulbar conjunctivae, cornea and iris)
0 = Blood vessels normal
1 = Some blood vessels definitely hyperaemic (injected)
2 = Diffuse, crimson colour, individual vessels not easily discernible.
3 = Diffuse beefy red.
Chemosis (sw): Lids and/or nictitating membranes the lids and hairs
just adjacent to
0 = No swelling.
1 = Any swelling above normal (includes nictitating membranes).
2 = Obvious swelling with partial eversion of lids
3 = Swelling with lids about half closed
4 = Swelling with lids more than half closed eye
Iris:*
0 = Normal
1 = Markedly deepened rugae, congestion, swelling, moderate circunicorneal hyperaemia, or injection, any of these or combination of any thereof, iris still reacting to light (sluggish reaction is positive).
2 = No reaction to light, haemorrhage, gross destruction (any or all of these).
Discharge (di):
0 = No discharge
1 = Any amount different from normal (does not include small amounts ob served in inner canthus of normal animals).
2 =Discharge with moistening of lids.
3 =Discharge with moistening of the lids and hairs, and considerable area around the eye
* Table according to the OECD guideline no. 405 (adopted February 24, 1987), EEC directive 92/69, L 383A, B. and EPA/OPPTS, 870.2400 (August 1998)
Calculation of primary irritation index:
Per animal and reading:
A = 5* (opacity)* (Area)
B = 5* (iris)
C = 2* (redness + swelling + discharge)
Individual irritation score (IIS):
IIS = A + B + C
Primary irritation score (PIS):
PIS = ∑(individual irritation scores of all treated animals after 24 h)+ ∑(individual irritation scores of all treated animals after 48h)+ ∑(individual irritation scores of all treated animals after 72 h) / N
with N= [3* (number of animals treated)]
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- details presented in the table below
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Remarks:
- Criteria used for interpretation of results: other: based on iris irritation at 72 h reading and non-reversibility after 21 days
- Conclusions:
- EU-classification: severely irritating (R41)
GHS-classification: serious eye damage category 1 - Executive summary:
The study was accomplished according to OECD guideline 405 (acute eye irritation / corrosion).
An amount of 0.1 ml test substance was instilled into the right eye of 3 rabbits; the left eye served as control. Effects were recorded 1 h, 1 d, 2 d, 3 d, 8 d, 15 d & 21 d after instillation.
Conclusion: The test substance is highly irritating to the eyes (EU-classification: severely irritating (R41), GHS-classification: serious eye damage category 1).
Reference
Animal |
1 |
2 |
3 |
Identification No |
0377 |
0391 |
0397 |
Weight (kg) |
2.62 |
2.72 |
2.62 |
Gender |
male |
female |
female |
Grading was done according to OECD guideline 405:
Readings |
Animal |
Cornea |
Iris |
Conjunctiva |
Symptoms |
Individual irritation score |
|||
op |
ar |
red |
sw |
di |
|||||
1h |
1 |
0 |
0 |
1 |
2 |
2 |
2 |
PV |
17 |
2 |
0 |
0 |
0 |
2 |
2 |
3 |
14 |
||
3 |
0 |
0 |
0 |
3 |
2 |
3 |
16 |
||
Mean |
16 |
||||||||
24h |
1 |
1 |
4 |
1 |
2 |
1 |
1 |
PV |
35 |
2 |
1 |
4 |
1 |
2 |
2 |
2 |
E/PV |
37 |
|
3 |
0 |
0 |
1 |
3 |
2 |
2 |
17 |
||
Mean |
30 |
||||||||
48h |
1 |
1 |
4 |
2 |
2 |
1 |
1 |
PV |
38 |
2 |
1 |
4 |
1 |
2 |
1 |
2 |
E/PV |
35 |
|
3 |
0 |
0 |
0 |
2 |
0 |
1 |
NA |
6 |
|
Mean |
26 |
||||||||
72h |
1 |
1 |
4 |
2 |
2 |
1 |
1 |
PV |
38 |
2 |
1 |
4 |
1 |
2 |
0 |
2 |
E/PV |
35 |
|
3 |
0 |
0 |
0 |
2 |
0 |
0 |
NA |
4 |
|
Mean |
26 |
||||||||
8d |
1 |
1 |
3 |
1 |
1 |
0 |
0 |
NA |
22 |
2 |
2 |
3 |
0 |
1 |
0 |
0 |
CV/NA/HF |
32 |
|
3 |
0 |
0 |
0 |
0 |
0 |
0 |
NA |
0 |
|
Mean |
18 |
||||||||
21d |
1 |
1 |
2 |
0 |
1 |
0 |
0 |
CV/NA |
12 |
2 |
2 |
3 |
1 |
2 |
0 |
0 |
CV/NA |
41 |
|
3 |
0 |
0 |
0 |
0 |
0 |
0 |
NA |
0 |
|
Mean |
18 |
Calculation: 245 / 9 = 27 (rounded in whole numbers)
Primary irritation score: 27
Abbriviations of symptoms:
CV: cornea vascularisation
E: suppuration
HF: alopecia
NA: scar formation
PV: miosis
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In an in vitro skin corrosion study, the cell survival rate after a one-hour exposure to ethylene glycol hexyl ether was 9%, which indicates that the test substance is corrosive to skin. This is supported by the results of 2 in vivo studies leading to irreversible skin damage.
Ethylene glycol mono hexyl ether was evaluated for skin irritation in 6 rabbits. Under the conditions of the study, ethylene glycol hexyl ether produced mild to moderate reversible skin irritation after a 3-minute exposure. However, severe irreversible alteration of the skin was evident in one of the six animals after a 3-minute exposure. There was irreversible alteration of the skin of three of the six animals after a 60-minute exposure; and irreversible alteration of the skin of all six animals after a 4-hour exposure. In another study, a 4-hour application of 0.5 ml of ethylene glycol mono hexyl ether to occluded rabbit skin resulted in minor to moderate erythema on 5 of 6 rabbits and moderate edema on 4. After one day, necrosis was apparent on 3 females and persisted through 7 days. No erythema or edema remained after 7 days. Four rabbits exhibited desquamation.
Ethylene glycol mono hexyl ether was evaluated for eye irritation in rabbits. Instillation of 0.1 ml test substance produced irreversible effects in 2 out of 3 animals. Instillation of 0.005 ml of the substance into rabbit eyes produced slight eye irritation.
Justification for selection of skin irritation / corrosion
endpoint:
reliable study
Justification for selection of eye irritation endpoint:
reliable study
Effects on skin irritation/corrosion: corrosive
Effects on eye irritation: irritating
Justification for classification or non-classification
Based on the results of the in vitro skin corrosion study and the in vivo skin irritation studies, ethylene glycol hexyl ether should be classified as corrosive (R34, and CLP category 1b).
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