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EC number: 206-059-0 | CAS number: 298-14-6
- 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
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- Oxidation reduction potential
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- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
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- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
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- Endpoint summary
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- 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
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- 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
Reliable studies on skin and eye irritation performed according to US guideline (FDA, Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics, 1959) are available. Potassium hydrogencarbonate when applied for 24 hours under occlusion to the intact skin of rabbits induced no skin reactions at all. In the eye irritation study potassium hydrogencarbonate induced transient slight irritation. Mean eye irritation scores were less than those triggering a classification according to CLP Regulation (EC) No 1272/2008.
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test procedure according to national (US) standards
- Qualifier:
- according to guideline
- Guideline:
- other: FDA, Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics, 1959
- Principles of method if other than guideline:
- Test substance was applied to two sites per animal, an abraded and an intact site, and held under occlusive dressing for 24 hours
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: H. Fortkamp, 4540 Lengerich, Germany
- Age at study initiation: 11 -17 weeks, male
- Weight at study initiation: 2.39 - 2.87 kg
- Housing: individual in screen bottom cages
- Diet: ad libitum, Ssniff K, laboratory rabbit chow (Ssniff Versuchstier-Diäten GmbH, 4770 Soest/ Westfalen, Germany)
- Water: tap water, ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 23 °C
- Humidity (%): 40 - 70 %
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 hours dark/light cycle - Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved, one site abraded, one site intact
- Vehicle:
- physiological saline
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg test substance per application site (as delivered by the sponsor), moistened with physiological saline - Duration of treatment / exposure:
- 24 hour(s)
- Observation period:
- 72 hours
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- % coverage: trunk
- Type of wrap if used: occlusive
The dorsal area of the trunk of six rabbits was clipped one day before treatment with an electric clipper (Aesculap Favorita II).
Before start of treatment the right sites of each animal were scarified to induce a lesion of stratum corneum, without cause of bleeding or injury of the dermis.
A portion of 500 mg test substance was moistened with physiological saline and applied to each of the test sites, on abraded and one intact per animal and covered with a 2.5 x 2.5 cm gauze patch.
The gauze patch was secured with a self-adhesive, occlusive dressing. After 24 hours the coverings were removed and remaining test substance was wiped off with a disposal paper. Animals were examined for signs of erythema and edema one to two hours, and 48 hours after patch removal.
SCORING SYSTEM: as stipulated by Draize (1959) - Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- mean
- Remarks:
- #1, #2, #3, #4, #5, #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: no reading at 48 h
- Irritation parameter:
- edema score
- Remarks:
- intact skin
- Basis:
- mean
- Remarks:
- #1, #2, #3, #4, #5, #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: no reading at 48 h
- Irritant / corrosive response data:
- Intact skin: sites were free of erythema and edema at both readings 24 and 72 hours after substance application (= 1 and 48 hour(s) after patch removal).
Abraded skin: very slight erythema (score 1), with partly slight, white discolorations was observed in all animals at both readings 24 and 72 hours after substance application (= 1 and 48 hour(s) after patch removal). At both readings abraded skin sites were free of edema. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- Classification is based on erythema/eschar and oedema of intact skin calculated as mean scores following grading at 24 and 72 hours after substance application, in consideration of reversibility.
According to CLP, EU GHS (Regulation (EC) No 1272/2008) "Kaliumbikarbonat" (potassium hydrogencarbonate) is classified as non skin irritant. - Executive summary:
In a primary dermal irritation study according to FDA, Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics, 1959, six New Zealand White rabbits were dermally exposed to 500 mg of test substance “Kaliumbikarbonat” (potassium hydrogencarbonate) per test site. The substance was administered for 24 hours to abraded and intact shaved body surface areas of 2.5 cm² each under occlusive conditions. Animals then were observed for further 48 hours. Irritation was scored by the method stipulated by Draize 1959 one to two hours, and 48 hours after patch removal (= 24 and 72 hours readings).
The intact skin sites were free of erythema and edema at both readings 24 and 72 hours after substance application.
The abraded skin sites of all animals showed a very slight erythema (score 1), with partly slight, white discolorations at both readings 24 and 72 hours after substance application. At both readings abraded skin sites were free of edema.
In this study, test substance "Kaliumbikarbonat" (potassium hydrogencarbonate) is not a dermal irritant.
No classification for skin irritation/corrosion is justified for "Kaliumbikarbonat" (potassium hydrogencarbonate) according to the following regulations:
- CLP - (EU-GHS), Regulation (EC) No 1272/2008
- OECD GHS (2nd rev. edition, UN, 2007)
According to the skin irritation/corrosion test guidelines EU Method B.4 and OECD TG 404 stipulated in COUNCIL REGULATION (EC) No 440/2008, only intact skin should be treated. Therefore, reactions of abraded skin are not included in the classification given above.
Reference
Intact skin: all readings were 0.
Abreaded skin: 24 and 72 hours after test substance application (= 1 and 48 hour(s) after patch removal): erythema score 1, with partly slight, white discolorations in 6/6 animals; edema score 0 in 6/6 animals
Average skin irritation index (Primary Dermal Irritation Index (PDII), maximal possible index of 8) calculated by the study authors: 0.5. Effects on intact and abraded skin were included in the index calculation.
Based on this Index the test item was considered to be a mild skin irritant by the study authors.
Scheme for interpretation of results used by the study authors:
Primary Skin Irritation Score (PDII)
0 : non irritant
> 0 - 2: mild irritant
> 2 - 5: moderate irritant
> 5: severe irritant
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:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test procedure according to national (US) standards comparable to international guidelines
- Qualifier:
- according to guideline
- Guideline:
- other: FDA, Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics, 1959
- Principles of method if other than guideline:
- Draize Test
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: not reported
- Age at study initiation: not reported
- Weight at study initiation: 2.55 - 3.33 kg
- Housing: not reported
- Diet: ad libitum, Ssniff K, laboratory rabbit chow (Ssniff Versuchstier-Diäten GmbH, 4770 Soest/ Westfalen, Germany)
- Water: tap water, ad libitum
- Acclimation period: not reported
ENVIRONMENTAL CONDITIONS
- Temperature (°C): not reported
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): not reported
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): instilled undiluted in the original state as delivered by the sponsor - Duration of treatment / exposure:
- eyes were not rinsed
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6 male rabbits
- Details on study design:
- The animals were treated with 0.1 ml of the test article, which was instilled into the conjunctival sac of the left eye after gently pulling the lower lid away from the eyeball. The lid was then gently held together for about one to two seconds, afterwards animals were returned to their cages.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM:
- as stipulated by Draize 1959 and guideline for acute eye irritation of US Interagency Regulatory Liaison Group (IRLG) Testing Standards and Guidelines Work Group (January 1981)
READINGS:
- 1 hour, 1, 2, 3, 4 and 7 days after instillation of test substance
TOOL USED TO ASSESS SCORE:
- 24 hours before treatment eyes were examined for lesions after application of fluorescein 0.15 %. - Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, #3, #4, #5, #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, #3, #4, #5, #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #2, #6
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 day in one animal
- Remarks on result:
- other: no observation beyond 7 days, clear tendency to reversibility from day 4 onward
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #3, #4
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 day in one animal
- Remarks on result:
- other: no observation beyond 7 days, clear tendency to reversibility from day 3 onward
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #4
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: #3, #6
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Irritant / corrosive response data:
- No effects on iris were observed. 1/6 animals showed a transient corneal opacity score 1 one hour after substance application. Mild or moderate conjunctival redness and discharge and moderate or severe chemosis were observed in all animals at the first scoring one hour after substance instillation (conjuncival redness score 1 in 2/6 and score 2 in 4/6 animals, chemosis score 2 score in 5/6 and score 3 in 1/6 animals, discharge score 1 in 5/6 and score 2 in 1/6 animals). A tendency to reversibility was seen from scoring at day 1 onward. All animals were free of corneal opacity one day after treatment. Conjunctival redness was fully reversible in 4/6 animals and almost reversible in the remaining 2/6 animals within the observation period of 7 days. Chemosis and discharge were fully reversible in all animals at day 4.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Judgment is based on effects on the cornea, iris and conjunctiva calculated as mean scores following grading at 24, 48 and 72 hours after instillation of the test material, in consideration of reversibility.
Test substance induced neither substantial corneal opacity nor iritis. Mean values of eye response at 24, 48 and 72 h for conjunctival redness and chemosis were less than those triggering a classification according to CLP Regulation (EC) No 1272/2008 and reversibility of effects can be assumed. Therefore, no classification for serious eye damage/eye irritation is justified for test substance "Kaliumbikarbonat" (potassium hydrogencarbonate) according to Regulation (EC) No 1272/2008. - Executive summary:
In a primary eye irritation study according to FDA (Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics, 1959), 0.1 ml of test substance "Kaliumbikarbonat" (potassium hydrogencarbonate) was instilled into the conjunctival sac of 6 male New Zealand White rabbits. The eyes were not rinsed after substance application. Animals then were observed for 7 days. Irritation was scored by the method of Draize. No effects on iris were observed. 1/6 animals showed a transient corneal opacity score 1 one hour after substance application. Mild or moderate conjunctival redness and discharge and moderate or severe chemosis were observed in all animals at the first scoring one hour after substance instillation (conjuncival redness score 1 in 2/6 and score 2 in 4/6 animals, chemosis score 2 score in 5/6 and score 3 in 1/6 animals, discharge score 1 in 5/6 and score 2 in 1/6 animals). A tendency to reversibility was seen from scoring at day 1 onward. All animals were free of corneal opacity one day after treatment. Conjunctival redness was fully reversible in 4/6 animals and almost reversible in the remaining 2/6 animals within the observation period of 7 days. Chemosis and discharge were fully reversible in all animals at day 4. The observation time did not extend beyond 7 days, even through slight eye responses were still present at that time. Sinve, ocular lesions showed a clear tendency of reversibility, there are no indications that these effects would not be reversible after 21 days. At study termination, reversibility was complete in 4/6 animals and almost complete in the remaining 2/6 animals. Therefore, a full reversibility in all animals is very likely if the observation period would have been extended to 21days, as required according to recent guidelines. Test substance induced neither substantial corneal opacity nor iritis. Mean values of eye response at 24, 48 and 72 h for conjunctival redness and chemosis were less than those triggering a classification according to CLP Regulation (EC) No 1272/2008. Study was terminated at study day 7 before ocular lesions fully reversed in all animals. However, fully reversibility can be assumed. Therefore, the test substance “Kaliumbikarbonat” (potassium hydrogencarbonate) was considered not irritating.
According to the eye irritation/corrosion test guidelines EU Method B.5 and OECD TG 405 stipulated in COUNCIL REGULATION (EC) No 440/2008, observation to full reversibility or 21 days is claimed. This is not fulfilled by this study, since study was terminated before eye effects completely reversed in all animals.However, complete reversibility can be assumed from healing process.
No classification for serious eye damage/eye irritation is justified for "Kaliumbikarbonat" (potassium hydrogencarbonate) according to the following regulations:
- CLP - (EU-GHS), Regulation (EC) No 1272/2008
- OECD GHS, (2nd rev. edition, UN, 2007)
Reference
rritant/corrosive response data for each animal at each observation time
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctivae |
Chemosis |
Discharge |
|
Max. score: 4 |
Area affected |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
Max.score: 3 |
|
1 hour |
1/0/0/0/0/0 |
4/0/0/0/0/0 |
0/0/0/0/0/0 |
2/2/2/2/1/1 |
2/3/2/2/2/2 |
1/1/1/1/1/2 |
Day 1 (24 hours) |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
1/2/2/2/1/2 |
1/2/1/1/2/2 |
0/1/1/0/1/1 |
Day 2 (48 hours) |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
1/2/2/2/1/2 |
0/2/1/0/2/1 |
0/1/1/0/1/1 |
Day 3 (72 hours) |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0/2/1/1/1/2 |
0/2/1/0/0/0 |
0/0/1/0/0/0 |
Day 4 |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0/1/1/1/1/1 |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
Day 7 |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0/1/1/0/0/0 |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
Average 24h, 48h, 72h |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0.67/2/1.67/1.67/1/2 |
0.33/2/1/0.33/1.33/1 |
0/0.67/1/0/0.67/0.67 |
Reversibility # |
c |
c |
n* |
c |
c |
# Reversibility: c. = completely reversible; n.c.= not completely reversible; n. = not reversible
* The observation time did not extend beyond 7 days, even through slight eye responses were still present at that time, therefore, the reversibility of the eye effects cannot be proved. However, ocular lesions showed a clear tendency of reversibility. At study termination, reversibility was complete in 4/6 animals and almost complete in the remaining 2/6 animals. Therefore, a full reversibility in all animals is very likely if the observation period would have been extended to 21days, as required according to recent guidelines.
Mean Total Scores (MTS) according to Kay and Calandra were calculated and used for classification by the study authors:
1h: MTS = 13.3
1d: MTS = 7.7
2d: MTS = 6.7
3d: MTS = 3.7
4d: MTS = 1.7
7d: MTS = 0.7
Maximum Mean Total Score (MMTS) possible: 110)
Based on these mean scores, according to the classification scheme of Kay and Calandra the test item was considered to be mild irritating (class 4 of maximum possible 8) by the study authors.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In a primary dermal irritation study according to FDA, Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics, 1959, six New Zealand White rabbits were dermally exposed to 500 mg of test substance “Kaliumbikarbonat” (potassium hydrogencarbonate) per test site. The substance was administered for 24 hours to abraded and intact shaved body surface areas of 2.5 cm² each under occlusive conditions. Animals then were observed for further 48 hours. Irritation was scored by the method stipulated by Draize 1959 one to two hours, and 48 hours after patch removal (= 24 and 72 hours readings).
The intact skin sites were free of erythema and edema at both readings 24 and 72 hours after substance application.
The effects on abraded skin are not relevant for classification according to CLP Regulation (EC) No 1272/2008 or Directive 67/548/EEC. The abraded skin sites of all animals showed a very slight erythema (score 1), with partly slight, white discolorations at both readings 24 and 72 hours after substance application. At both readings abraded skin sites were free of edema.
In a primary eye irritation study according to FDA (Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics, 1959), 0.1 ml of test substance "Kaliumbikarbonat" (potassium hydrogencarbonate) was instilled into the conjunctival sac of 6 male New Zealand White rabbits. The eyes were not rinsed after substance application. Animals then were observed for 7 days. Irritation was scored by the method of Draize.
No effects on iris were observed. 1/6 animals showed a transient corneal opacity score 1 one hour after substance application. Mild or moderate conjunctival redness and discharge and moderate or severe chemosis were observed in all animals at the first scoring one hour after substance instillation (conjunctival redness score 1 in 2/6 and score 2 in 4/6 animals, chemosis score 2 score in 5/6 and score 3 in 1/6 animals, discharge score 1 in 5/6 and score 2 in 1/6 animals). A tendency to reversibility was seen from scoring at day 1 onward. All animals were free of corneal opacity one day after treatment. Conjunctival redness was fully reversible in 4/6 animals and almost reversible in the remaining 2/6 animals within the observation period of 7 days. Chemosis and discharge were fully reversible in all animals at day 4.
The observation time did not extend beyond 7 days, even through slight eye responses were still present at that time, therefore, the reversibility of the eye effects cannot be proved. However, ocular lesions showed a clear tendency of reversibility. At study termination, reversibility was complete in 4/6 animals and almost complete in the remaining 2/6 animals. Thus, complete reversibility is very likely if the observation period would have been extended to up to 21 days, as required according to recent guidelines.
Potassium hydrogencarbonate is considered not irritating, as neither iritis nor substantial corneal opacity was induced, calculated mean scores for conjunctival redness and chemosis following grading at 24, 48 and 72 h after instillation were less than those triggering a classification according to CLP Regulation (EC) No 1272/2008 and complete reversibility is assumed.
Justification for classification or non-classification
A non-classification of potassium hydrogencarbonate is justified for skin and eye irritation according to CLP Regulation (EC) No 1272/2008 in consideration of the results of reliable animal studies.
Potassium hyrogencarbonate when applied for 24 hours under occlusion to the intact skin of rabbits induced no skin reactions at all.
Classification of eye irritation is based on effects on cornea, iris and conjunctiva calculated as mean scores following grading at 24, 48 and 72 hours after instillation of the test material, in consideration of reversibility. Potassium hydrogencarbonate induced neither substantial corneal opacity nor iritis. Mean values of eye response at 24, 48 and 72 h for conjunctival redness and chemosis were less than those triggering a classification according to CLP Regulation (EC) No 1272/2008. Study was terminated at study day 7 before ocular lesions fully reversed in all animals. However, at study termination, reversibility was complete in 4/6 animals and almost complete in the remaining 2/6 animals. Complete reversibility is very likely if the observation period would have been extended to up to 21 days, as required according to recent guidelines. Thus, no classification for serious eye damage/eye irritation is justified according to CLP Regulation (EC) No 1272/2008.
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