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EC number: 700-291-0 | CAS number: 1000701-92-7
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- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
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- Density
- Particle size distribution (Granulometry)
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- Nanomaterial agglomeration / aggregation
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- Endpoint summary
- Stability
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
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- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
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- Terrestrial toxicity
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- 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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP study according to OECD guideline 405 (acute eye irritation/corrosion) study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- 2-hexyloxyethanol
- EC Number:
- 203-951-1
- EC Name:
- 2-hexyloxyethanol
- Cas Number:
- 112-25-4
- Molecular formula:
- C8H18O2
- IUPAC Name:
- 2-(hexyloxy)ethanol
- Reference substance name:
- Hexylglycol (EGHE)
- IUPAC Name:
- Hexylglycol (EGHE)
- Details on test material:
- - Name of test material (as cited in study report): n-Hexlglykol; Substance No. 83/145
- Expiration date of the lot/batch: 05/85
Constituent 1
Constituent 2
Test animals / tissue source
- 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
Test system
- 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)]
Results and discussion
In vivo
Results
- Irritation parameter:
- other: primary irritation score
- Basis:
- mean
- Max. score:
- 27
- Reversibility:
- not reversible
- Irritant / corrosive response data:
- details presented in the table below
Any other information on results incl. tables
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
Applicant's summary and conclusion
- Interpretation of results:
- highly irritating
- Remarks:
- Migrated information 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).
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