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EC number: 700-347-4 | CAS number: -
- 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
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The study was performed between 02 September 2009 and 07 September 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
- Qualifier:
- according to guideline
- Guideline:
- other: EU Guideline Testing of Chemicals B46
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Draft Test Guideline (version 4)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Date of inspectection: 19-08-2009 Date of Signature: 04-03-2009
- Species:
- other: reconstituted human epidermis model
- Strain:
- other: reconstituted human epidermis model
- Details on test animals or test system and environmental conditions:
- Not applicable
- Type of coverage:
- other: Topical
- Preparation of test site:
- other: Not applicable
- Vehicle:
- other: No vehicle used
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- The test Material was applied neat.
- Amount(s) applied (volume or weight with unit):
10µl of of the test material was applied to the epidermis surface.
- Concentration (if solution):
The test material was used as supplied.
VEHICLE
No vehicle used - Duration of treatment / exposure:
- 15 Minutes & 42 hour post exposure incubation
- Observation period:
- Not applicable
- Number of animals:
- Not applicable
- Details on study design:
- TEST SITE
- Area of exposure:
10µl of the test material was applied to the epidermis surface.
- % coverage:
The test material was applied topically to the corresponding tissues ensuring uniform covering.
- Type of wrap if used:
None used
REMOVAL OF TEST SUBSTANCE
- Washing (if done):
At the end of the exposure period, each tissue was removed from the well using forceps and rinsed using a wash bottle containing PBS with Ca++ and Mg++. Rinsing was achieved by filling and emptying each tissue insert for approximately 40 seconds using a constant soft stream of PBS to gently remove any residual test material.
- Time after start of exposure:
15 Minutes post exposure
SCORING SYSTEM:
Quantitative MTT Assessment (percentage tissue viability)
For the test material the relative mean tissue viabilities obtained after the 15 minute treatment followed by the 42 hour post-exposure incubation period were compared to the mean of the negative control treated tissues (n=3). The relative mean viabilities were calculated in the following way:
mean OD540 of test material / mean OD540 of negative control x 100 = Relative mean tissue viability (percentage of negative control)
Classification of irritation potential is based upon relative tissue viability following the 15 minute exposure period followed by the 42 hour post-exposure incubation period according to the following:
Mean tissue viability is ≤50% : Irritant (I) R38
Mean tissue viability is >50% : Non-Irritant (NI) - Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 15-minute exposure
- Value:
- 36.8
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- The relative mean viability of the test material treated tissues was 36.8% after a 15-minute exposure.
- Other effects:
- No
- Interpretation of results:
- irritating
- Remarks:
- Migrated information EXAMPLE Criteria used for interpretation of results: expert judgment
- Conclusions:
- The test material was considered to be an Irritant.
- Executive summary:
- Introduction: The
purpose of this test was to evaluate the skin irritation potential of the
test material using the EPISKINTM
reconstituted human epidermis model after a treatment
period of 15 minutes followed by a post-exposure incubation period of
42 hours. The principle of the assay was based on the measurement of
cytotoxicity in reconstituted human epidermal cultures following topical
exposure to the test material by means of the colourimetric MTT reduction
assay. Cell viability is measured by enzymatic reduction of the yellow MTT
tetrazolium salt (3 -[4,5-dimethylthiazol-2-yl]-2,5-diphenyl-tetrazolium
bromide) to a blue formazan salt (within the mitochondria of viable cells)
in the test material treated tissues relative to the negative
controls. The concentration of the inflammatory mediator IL-1α in the
culture medium retained following the 42 hour post-exposure incubation
period is also determined for test materials which are found to be
borderline non-irritant based upon the MTT reduction endpoint. This
complimentary end-point will be used to either confirm a non-irritant
result or will be used to override the non-irritant result.
Methods:
Triplicate tissues were treated with the test material for an exposure period of 15 minutes. At the end of the exposure period each tissue was rinsed before incubating for approximately 42 hours. At the end of the post-exposure incubation period each tissue was taken for MTT-loading. The maintenance medium from beneath each tissue was transferred to pre-labelled micro tubes and stored in a freezer for possible inflammatory mediator determination. After MTT loading a total biopsy of each epidermis was made and placed into micro tubes containing acidified isopropanol for extraction of formazan crystals out of the MTT-loaded tissues.
At the end of the formazan extraction period each tube was mixed thoroughly and duplicate 200µl samples were transferred to the appropriate wells of a pre-labelled 96 -well plate. The optical density was measured at 540 nm.
Data are presented in the form of percentage viability (MTT reduction in the test material treated tissues relative to negative control tissues).
Results:
The relative mean viability of the test material treated tissues was 36.8% after a 15 -minute exposure.
Quality criteria:
The quality criteria required for acceptance of results in the test were satisfied.
Reference
RESULTS
Direct MTT Reduction
The MTT solution containing the test material did not turn blue/purple which indicated that the test material did not directly reduce MTT.
Test Material, Positive Control Material and Negative Control Material
The individual and mean OD540 values, standard deviations and tissue viabilities for the test material, negative control material and positive control material are given in Table 1. The mean viabilities and standard deviations of the test material and positive control, relative to the negative control are also given in Table 1.
The qualitative evaluation of tissue viability is given in Table 2.
Following the 15-minute exposure the test material treated tissues appeared blue/white which was considered indicative of viable tissue.
Quality Criteria
The relative mean tissue viability for the positive control treated tissues was ≤40% relative to the negative control treated tissues and the standard deviation value of the percentage viability was ≤20%. The positive control acceptance criterion was therefore satisfied.
The mean OD540 for the negative control treated tissues was ≥0.6 and the SD value of the percentage viability was ≤20%. The negative control acceptance criterion was therefore satisfied.
Table1 : Mean OD540 Values and Percentage Viabilities for the Negative Control Material, Positive Control Material and Test Material
Material |
OD540of tissues |
Mean OD540of triplicate tissues |
±SD of OD540 |
Relative individual tissue viability (%) |
Relative mean viability (%) |
Negative Control Material |
0.966 |
0.916 |
0.05 |
105.5 |
100* |
0.912 |
99.6 |
||||
0.870 |
95.0 |
||||
Positive Control Material |
0.085 |
0.073 |
0.01 |
9.3 |
8.0 |
0.078 |
8.5 |
||||
0.057 |
6.2 |
||||
Test Material |
0.341 |
0.337 |
0.02 |
37.2 |
36.8 |
0.351 |
38.3 |
||||
0.320 |
34.9 |
SD= Standard Deviation
*= The mean viability of the negative control tissues is set at 100%
Table2 : Qualitative Evaluation of Tissue Viability (MTT uptake visual evaluation)
Material |
Tissue 1 |
Tissue 2 |
Tissue 3 |
Negative Control Material |
- |
- |
- |
Positive Control Material |
++ |
++ |
++ |
Test Material |
+ |
+ |
+ |
MTT
visual scoring scheme
- = blue tissue (viable)
+ = blue/white tissue (semi-viable)
++ = tissue is completely white (dead
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation
- Remarks:
- other: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The study was performed on 13 November 2009.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
- Qualifier:
- no guideline followed
- Guideline:
- other: The rabbit enucleated eye test is used (in-house), as a first stage in the assessment of ocular irritancy potential.
- Deviations:
- no
- Principles of method if other than guideline:
- The study was designed to assess the ocular irritancy potential of the test material in the rabbit following application onto the cornea of the enucleated eye.
The rabbit enucleated eye test is used (in-house), as a first stage in the assessment of ocular irritancy potential. The preferred species of choice is the rabbit. The assay has undergone inter-laboratory validation and has been shown to reliably detect test materials that are negligible, or moderate to severe ocular irritants.
The strain of rabbit used in these laboratories has been shown to produce satisfactory responses using known ocular-irritants and non-ocular irritants during in-house validation (see attached Appendix 3). The results of the study are believed to be of value in predicting the ocular irritancy potential of the test material in man. - GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Prior to enucleation, the eyes of the provisionally selected rabbits were examined for evidence of ocular irritation or defect, following application of Fluorescein Sodium drops BP (1% w/v). Examination was aided with the Kowa SL-5 slit-lamp biomicroscope (Keeler Ltd, Windsor, Berks; UK). Corneal thickness values were also recorded using the DGH-1000 Ultrasonic pachymeter (DGH Technology Inc, Solana Beach, CA). Only animals whose eyes showed no evidence of ocular irritation or defect were used for testing purposes.
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- For the purpose of the study the test material was used as supplied.
- Controls:
- other: Two enucleated eyes were treated, for control purposes, with saline solution (0.9% Sodium Chloride).
- Amount / concentration applied:
- The test material was used undiluted as supplied. A volume of 0.1 ml of the test material was applied as evenly as possible to the surface of the cornea.
- Duration of treatment / exposure:
- After ten seconds the test material was washed off the cornea using a minimum of 20 ml of saline solution (approximately 32°C).
- Observation period (in vivo):
- Assessment of corneal cloudiness was made pre-enucleation, post equilibration and approximately 60, 120, 180 and 240 minutes following treatment.
The thickness of the cornea was measured using an ultrasonic pachymeter. Measurements for corneal thickness were carried out pre-enucleation, post equilibration and approximately 60, 120, 180 and 240 minutes following treatment.
The condition of the corneal epithelium was assessed approximately 60, 120, 180 and 240 minutes following treatment.
The uptake of fluorescein by the corneal epithelium was assessed pre-enucleation, post equilibration and approximately 240 minutes following treatment. - Number of animals or in vitro replicates:
- Three eyes were treated with test material, two additional eyes remained untreated for control purposes.
- Details on study design:
- Test Material Administration
Three eyes were treated with test material, two additional eyes remained untreated for control purposes. The treatment eye was removed from the superfusion apparatus whilst still being held in the perspex clamp. The clamp/eye was then placed horizontally into a petri dish.
The test material was used undiluted as supplied. A volume of 0.1 ml of the test material was applied as evenly as possible to the surface of the cornea. After ten seconds the test material was washed off the cornea using a minimum of 20 ml of saline solution (approximately 32°C).
Observations
Assessment of corneal cloudiness was made pre-enucleation, post equilibration and approximately 60, 120, 180 and 240 minutes following treatment, according to the numerical evaluation given in Appendix 2 adopted from Advances in Modern Toxicology: Dermatoxicology, 4th Ed, (F Marzulli and H Maibach, eds) Hemisphere Publishing Corporation, Washington DC, 1991, pp 749-815.
Examination of the eye was facilitated by use of a slit-lamp biomicroscope. The thickness of the cornea was measured using an ultrasonic pachymeter. For each enucleated eye a measurement was made at the optical centre, and at a further four locations at the apex of the cornea. A mean value for corneal thickness was then calculated. Measurements for corneal thickness were carried out pre-enucleation, post equilibration and approximately 60, 120, 180 and 240 minutes following treatment.
The condition of the corneal epithelium was assessed approximately 60, 120, 180 and 240 minutes following treatment. Assessment was facilitated by the use of the slit-lamp biomicroscope.
The uptake of fluorescein by the corneal epithelium was assessed pre-enucleation, post equilibration and approximately 240 minutes following treatment, according to the numerical evaluation given in attached Appendix 2. This was carried out using the cobalt blue filter of the slit lamp biomicroscope, following application of Fluorescein Sodium drops. - Irritation parameter:
- cornea opacity score
- Remarks:
- Corneal Opacity
- Basis:
- other: Maximum score
- Time point:
- other: Maximum score
- Max. score:
- 1
- Reversibility:
- not specified
- Remarks:
- N/A
- Remarks on result:
- other: Maximum score for Corneal Opacity 1
- Irritation parameter:
- cornea opacity score
- Remarks:
- Area of corneal opacity
- Basis:
- other: Maximum score
- Time point:
- other: Maximum score
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks:
- N/A
- Remarks on result:
- other: Maximum score for Area of corneal opacity 3
- Irritation parameter:
- cornea opacity score
- Remarks:
- Corneal Swelling (%)
- Basis:
- other: Mean score
- Time point:
- other: 60 Minutes
- Score:
- 13.8
- Reversibility:
- not specified
- Remarks:
- N/A
- Remarks on result:
- other: Mean score @ 60 Minutes 13.8 %
- Irritation parameter:
- cornea opacity score
- Remarks:
- Corneal Swelling (%)
- Basis:
- other: Mean score
- Time point:
- other: 120 Minutes
- Score:
- 35.3
- Reversibility:
- not specified
- Remarks:
- N/A
- Remarks on result:
- other: Mean score @ 120 Minutes 35.3 % which meets or exceeds cut-off value indicating a severe ocular irritant
- Irritation parameter:
- cornea opacity score
- Remarks:
- Corneal Swelling (%)
- Basis:
- other: Mean score
- Time point:
- other: 240 Minutes
- Score:
- 58
- Reversibility:
- not specified
- Remarks:
- N/A
- Remarks on result:
- other: Mean score @ 240 Minutes 58.0 % which meets or exceeds cut-off value indicating a severe ocular irritant
- Irritation parameter:
- cornea opacity score
- Remarks:
- Condition of Corneal Epithelium
- Basis:
- other: Maximum score
- Time point:
- other: Maximum score
- Reversibility:
- not specified
- Remarks on result:
- other: Sloughing was seen which meets or exceeds cut-off value indicating a severe ocular irritant
- Irritant / corrosive response data:
- Corneal Opacity
Individual scores for corneal opacity are given in Table 1.
Some loss of transparency was noted in all test eyes. No corneal effects were noted in the control eyes during the study period.
Corneal Thickness and Condition
Individual and mean corneal thickness measurements and corneal swelling calculations are given in Table 2 and Table 3. The condition of the corneal epithelium following treatment is given in Table 4.
Corneal swelling of the test eyes during the study period was considerably greater than to that observed in the control eyes over the same period.
Sloughing of the corneal epithelium was noted in two test eyes. The condition of the corneal epithelium of one test eye and the control eyes appeared normal during the study period.
Fluorescein Uptake
Individual scores for fluorescein uptake are given in Table 5.
Fluorescein uptake was noted in the test eyes 240 minutes following test material application. No fluorescein uptake was noted in the control eyes 240 minutes following treatment. - Interpretation of results:
- highly irritating
- Remarks:
- Migrated information Following assessment of the data for all endpoints, the test material was considered to have the potential to cause severe ocular irritancy in vivo. Criteria used for interpretation of results: expert judgment
- Conclusions:
- Following assessment of the data for all endpoints, the test material was considered to have the potential to cause severe ocular irritancy in vivo.
- Executive summary:
Introduction.
A study was performed to assess the ocular irritancy potential of the test material in the rabbit following application onto the cornea of the enucleated eye. The results of the study are believed to be of value in predicting the ocular irritation potential of the test material in man.
Methods.
0.1 ml of the test material was applied onto the cornea of each of three enucleated eyes which had been maintained at a temperature of 32°C ± 1.5°C within the superfusion chamber. A further two enucleated eyes were treated, for control purposes, with saline solution (0.9% Sodium Chloride).
Results.
Maximal ocular irritation observations recorded for the test eyes were as follows:
Corneal Opacity
Fluorescein Uptake
Corneal Swelling (%)
Condition of Corneal Epithelium
Test Eyesa
Control Eyesb
Cldy
Area
Int
Area
60
mins120
mins240
mins60
mins120
mins240
mins1
3
2
3
13.8
35.3+
58.0+
3.6
2.7
0.0
Sloughing+
Conclusion.
Following assessment of the data for all endpoints the test material was considered to have the potential to cause severe ocular irritancy in vivo.
a= For each time point the swelling recorded is the mean of three eyes
b= For each time point the swelling recorded is the mean of two eyes
Cldy= Corneal cloudiness
Int= Intensity of fluorescein uptake
Mins= Minutes following treatment
+= Meets or exceeds cut-off value indicating a severe ocular irritant
Reference
Interpretation of Results
The data for all endpoints was assessed and an estimate of the test material ocular irritancy potential was made based on the following cut-off values:
REET Parameter* |
REET Cut-Off Value |
Maximum Corneal Opacity (Corneal Cloudiness x Area) |
> or = 4 |
Maximum Fluorescein Uptake (Intensity x Area) |
> or = 4 |
Mean Corneal Swelling (mins): 60, 120, 240 |
> or = 25% |
Corneal Epithelium Observations |
Any with pitting, mottling or sloughing |
Endpoints included corneal opacity, condition of the corneal epithelium, fluorescein uptake (240 minutes following treatment) and the percentage change in corneal thickness (corneal swelling). For each test and control eye, the percentage change in corneal thickness following treatment (60, 120, 180 and 240 minutes) was calculated based upon the pre‑treatment value as follows:
(mean corneal thickness post – treatment) – (mean corneal thickness post equilibration) x 100
Mean corneal thickness post equilibration
A mean value for corneal swelling was then calculated for the test and control eyes for the 60, 120 and 240 minutes post treatment observation periods.
A negative ocular irritancy potential may require further investigation using an in vivo ocular irritation study.
*= Any parameter that meets or exceeds the cut-off values indicates a severe eye irritant.
Table1 Individual Scores for Corneal Opacity
|
Test Eyes |
Control Eyes |
||||||||||||||||||
Chamber Number |
1A |
3A |
5A |
2A |
4A |
|||||||||||||||
Time After Treatment (minutes) |
60 |
120 |
180 |
240 |
60 |
120 |
180 |
240 |
60 |
120 |
180 |
240 |
60 |
120 |
180 |
240 |
60 |
120 |
180 |
240 |
Degree of Corneal Opacity |
0 |
0 |
0 |
1 |
0 |
1 |
1 |
1 |
0 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Area of Corneal Opacity |
0 |
0 |
0 |
1 |
0 |
1 |
1 |
1 |
0 |
2 |
3 |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Table2 Individual Measurements for Corneal Thickness (µm)
Test Eyes |
|||||||||||||||||||||||||
Time After Treatment (minutes) |
60 |
120 |
180 |
240 |
|||||||||||||||||||||
Corneal Position |
oc |
1 |
2 |
3 |
4 |
mean |
oc |
1 |
2 |
3 |
4 |
mean |
oc |
1 |
2 |
3 |
4 |
mean |
oc |
1 |
2 |
3 |
4 |
mean |
|
Chamber Number |
1A |
408 |
450 |
397 |
386 |
398 |
407.8 |
434 |
468 |
443 |
425 |
460 |
446.0 |
435 |
521 |
443 |
457 |
497 |
470.6 |
460 |
630 |
453 |
457 |
523 |
504.6 |
3A |
426 |
423 |
401 |
420 |
422 |
418.4 |
441 |
587 |
425 |
551 |
529 |
506.6 |
455 |
657 |
431 |
592 |
612 |
549.4 |
463 |
677 |
444 |
682 |
693 |
581.0 |
|
5A |
439 |
437 |
441 |
437 |
443 |
439.4 |
502 |
455 |
575 |
621 |
631 |
556.8 |
736 |
459 |
640 |
705 |
703 |
648.6 |
721 |
471 |
699 |
756 |
753 |
680.0 |
|
|
|||||||||||||||||||||||||
Control Eyes |
|||||||||||||||||||||||||
Time After Treatment (minutes) |
60 |
120 |
180 |
240 |
|||||||||||||||||||||
Corneal Position |
oc |
1 |
2 |
3 |
4 |
mean |
oc |
1 |
2 |
3 |
4 |
mean |
oc |
1 |
2 |
3 |
4 |
mean |
oc |
1 |
2 |
3 |
4 |
mean |
|
Chamber Number |
2A |
389 |
353 |
362 |
383 |
362 |
369.8 |
386 |
337 |
365 |
373 |
359 |
364.0 |
369 |
343 |
345 |
360 |
352 |
353.8 |
363 |
329 |
343 |
355 |
354 |
348.8 |
4A |
421 |
374 |
373 |
404 |
398 |
394.0 |
411 |
376 |
372 |
403 |
405 |
393.4 |
401 |
367 |
372 |
390 |
384 |
382.8 |
400 |
369 |
355 |
383 |
371 |
375.6 |
oc= Optical centre
Table3 Determination of Corneal Swelling (%)
Test Eyes |
|||||||||||
Chamber Number |
Observation Period (minutes) |
Mean Corneal Thickness (µm) |
Corneal Swelling (%)a |
Chamber Number |
Observation Period (minutes) |
Mean Corneal Thickness (µm) |
Corneal Swelling (%)a |
Chamber Number |
Observation Period (minutes) |
Mean Corneal Thickness (µm) |
Corneal Swelling (%)a |
1A |
Post equilibration |
347.8 |
N/A |
3A |
Post equilibration |
368.0 |
N/A |
5A |
Post equilibration |
397.4 |
N/A |
60 Post treatment |
407.8 |
17.3 |
60 Post treatment |
418.4 |
13.7 |
60 Post treatment |
439.4 |
10.6 |
|||
120 Post treatment |
446.0 |
28.2 |
120 Post treatment |
506.6 |
37.7 |
120 Post treatment |
556.8 |
40.1 |
|||
180 Post treatment |
470.6 |
35.3 |
180 Post treatment |
549.4 |
49.3 |
180 Post treatment |
648.6 |
63.2 |
|||
240 Post treatment |
504.6 |
45.1 |
240 Post treatment |
581.0 |
57.9 |
240 Post treatment |
680.0 |
71.1 |
Control Eyes |
|
||||||||
Chamber Number |
Observation Period (minutes) |
Mean Corneal Thickness (µm) |
Corneal Swelling (%)a |
Chamber Number |
Observation Period (minutes) |
Mean Corneal Thickness (µm) |
Corneal Swelling (%)a |
Test Eyes |
|
Mean corneal swelling 1 hour following treatment 13.8% Mean corneal swelling 2 hours following treatment 35.3%+ Mean corneal swelling 4 hours following treatment 58.0%+ |
|||||||||
2A |
Post equilibration |
353.2 |
N/A |
4A |
Post equilibration |
384.4 |
N/A |
||
60 Post treatment |
369.8 |
4.7 |
60 Post treatment |
394.0 |
2.5 |
Control Eyes |
|||
120 Post treatment |
364.0 |
3.1 |
120 Post treatment |
393.4 |
2.3 |
Mean corneal swelling 1 hour following treatment 3.6% Mean corneal swelling 2 hours following treatment 3.8% Mean corneal swelling 4 hours following treatment 0.0% |
|||
180 Post treatment |
353.8 |
0.2 |
180 Post treatment |
382.8 |
0.0 |
||||
240 Post treatment |
348.8 |
0.0 |
240 Post treatment |
375.6 |
0.0 |
a= % Corneal swelling =
N/A= Not applicable
+ = Meets or exceeds cut-off value and therefore indicates a severe eye irritant
Table4 Corneal Epithelium Condition
Test Eyes |
||||
Chamber Number |
Time After Treatment (minutes) |
|||
60 |
120 |
180 |
240 |
|
1A |
Normal |
Normal |
Normal |
Normal |
3A+ |
Normal |
Sloughing |
Sloughing |
Sloughing |
5A+ |
Normal |
Sloughing |
Sloughing |
Sloughing |
Control Eyes |
||||
Chamber Number |
Time After Treatment (minutes) |
|||
60 |
120 |
180 |
240 |
|
2A |
Normal |
Normal |
Normal |
Normal |
4A |
Normal |
Normal |
Normal |
Normal |
+ = Meets or exceeds cut-off value indicating a severe ocular irritant
Table5 Individual Scores for Fluorescein Uptake (240 Minutes Post Dosing)
|
Test Eyes |
Control Eyes |
|||
Chamber Number |
1A |
3A |
5A |
2A |
4A |
Intensity of Fluorescein Uptake |
1 |
1 |
2 |
0 |
0 |
Area of Fluorescein Uptake |
2 |
2 |
3 |
0 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The test substance was found to be non-corrosive to skin in the OECD 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis) Test. In the OECD 439 (In Vitro Skin Irritation: reconstructed Human Epidermis) Test skin irritation effects were noted for the test substance. The very slight erythema observed in rats up to 4-5 days in the acute dermal toxicity study indicates that there is potential for skin irritation and the material is classified and labelled accordingly (CLP Category 2).
The ocular irritation potential of the test substance was tested in a rabbit enucleated eye test (REET) in place of an in vivo eye irritation test because the test substance was suspected to be strongly irritating and/or corrosive. Treatment of enucleated rabbit eyes with the undiluted test substance for 10 seconds resulted in increased corneal swelling, damage to the corneal epithelium and corneal opacity. Assessment of the data for all endpoints indicated the notified chemical has the potential to cause severe ocular irritancy in vivo. Accordingly, it is classified and labelled as causing serious eye damage (CLP Category 1).
Justification for selection of skin irritation / corrosion endpoint:
Only one study available
Justification for selection of eye irritation endpoint:
Only one study available
Effects on skin irritation/corrosion: irritating
Effects on eye irritation: highly irritating
Justification for classification or non-classification
The test data support classification of the registered substance as a skin irritant (Category 2) and severe eye irritant (Category 1) according to the criteria laid down in Regulation (EC) No 1272/2008 (i.e. CLP).
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