Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 617-638-6 | CAS number: 84868-02-0
- 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
Skin irritation/corrosion: The test material produced corrosive effects on contaminated skin (reference 7.3.1-1).
Eye irritation: In the primary eye irritation test no irritation of the cornea and iris was observed. The test item is not considered to be irritative (reference 7.3.2-1).
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
- Study period:
- 17-04-1991 to 09-07-1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- OECD 1981
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- Iva: NZW
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: SAVO-Ivanovas, Kisslegg
- Age at study initiation: 17 - 19 weeks
- Mean weight at study initiation: 3.33 (3.25 - 3.40) kg
- Housing: cages type KK 017 (floor area: 75 x 54.5 = 4087 cm2, height: 38 cm; manufacturer: Hulskamp) on metal grids
- Diet: Altromin Standard Diet TPFV 2113, pellets from an automatic drinking device ad libitum
- Water: acidified, fully demineralized water from an automatic drinking device ad libitum
- Acclimation period: more than 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 43 - 64
- Photoperiod (hrs dark / hrs light): daylight - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Remarks:
- the test material was moistened with aqua pro injectione
- Controls:
- no
- Amount / concentration applied:
- 0.5 g test item
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 3 animals - 1 male and 2 female
- Details on study design:
- TEST SITE
- Area of exposure: back side
- Type of wrap: polyethylene foil kept in place by a leather sleeve
REMOVAL OF TEST SUBSTANCE
- Washing: wiped off
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
1 hour after removal of the patches and afterwards daily for 14 days
SCORING SYSTEM: Draize and OECD 404 - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- left side
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- right side
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- left side
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- right side
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- left side
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- right side
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- left side
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- right side
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- left side
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- right side
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- left side
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- right side
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.9
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.97
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritant / corrosive response data:
- Skin alterations:
Single application of 0.5 g test item to the intact dorsal skin of rabbits, after a 4 hour period of exposure under occlusive conditions, led to severe skin irritation. Erythema (score 1 or 2) from day 1 until day 6 of the study was seen. Edema (score 1 - 3) was observed from day 1 up to day 8 of the study. Erythema and edema were followed by necrosis, large scales (as indicated by score 4), and small scales, which are indicative of corrosivity of the test material.
The cumulative mean scores for erythema and edema were:
Day 1 : 1.9
Day 2 : 2.2
Day 3 : 1.8
Though the cumulative scores for erythema and edema for days 1, 2, and 3 were not indicative of serious effects attention must be given to the corrosive effects. - Other effects:
- Signs of systemic toxicity, body weight, mortality:
No signs of systemic toxicity were detected. The body weight development corresponded to that of untreated rabbits of the same age. All rabbits survived the 15 day observation period. - Interpretation of results:
- Category 1 (corrosive) based on GHS criteria
- Conclusions:
- The test material produced corrosive effects on contaminated skin.
- Executive summary:
The primary skin irritation potential of the test item was investigated by topical application of 0.5 g to skin of the back and sides of each of three young adult New Zealand White rabbits in a OECD 404 study. The duration of treatment was four hours. The scoring of skin reactions was performed 1 hour after removal of the dressing and afterwards daily for 14 days. The scores of each animal at the following reading times (24, 48, 72 hours) were used in calculating the respective mean values for each type of lesion. In the primary skin irritation test slight and well-defined erythema (score 1 or 2) and edema were observed on the first days after application, and were followed by necrosis, large scales, and small scales later on, indicating corrosivity of the test material. Though the cumulative mean scores for erythema and edema for days 1, 2, and 3 were not indicative of serious effects, the test material produced corrosive effects on skin contaminated under conditions comparable to those of this test.
Reference
Skin irritation results
Animal No. |
Sex |
back site |
|
Local findings (study day) |
||||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
12 |
14 |
15 |
||||
91012 |
male |
left |
Erythema |
2 |
2 |
2 |
2 |
2 |
4 |
4 |
4 |
0 |
0 |
0 |
0 |
0 |
Edema |
2 |
3 |
2 |
2 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
Others |
|
|
|
|
|
G |
G |
0 |
S |
S |
S |
S |
S |
|||
right |
Erythema |
2 |
2 |
2 |
2 |
2 |
4 |
4 |
4 |
4 |
4 |
4 |
0 |
0 |
||
Edema |
2 |
3 |
3 |
3 |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
Others |
|
|
|
|
|
G |
G |
G |
G |
G |
G |
S |
S |
|||
91023 |
female |
left |
Erythema |
2 |
2 |
1 |
1 |
1 |
1 |
4 |
4 |
0 |
0 |
0 |
0 |
0 |
Edema |
2 |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
Others |
|
|
|
|
|
|
G |
G |
S |
S |
S |
S |
S |
|||
right |
Erythema |
2 |
2 |
1 |
1 |
1 |
1 |
4 |
4 |
0 |
0 |
0 |
0 |
0 |
||
Edema |
1 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
Others |
|
|
|
|
|
|
G |
0 |
S |
S |
S |
S |
S |
|||
91015 |
female |
left |
Erythema |
2 |
2 |
2 |
2 |
2 |
2 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
Edema |
2 |
3 |
2 |
2 |
2 |
2 |
2 |
2 |
0 |
0 |
0 |
0 |
0 |
|||
Others |
|
|
|
|
|
|
N |
N |
N |
N |
N |
GS |
0G |
|||
right |
Erythema |
2 |
2 |
2 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
||
Edema |
2 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
0 |
0 |
0 |
0 |
0 |
|||
Others |
|
|
|
N |
N |
N |
N |
N |
N |
N |
N |
NGS |
GS |
|||
Mean values |
Erythema |
2.0 |
2.0 |
1.7 |
|
|
|
|
|
|
|
|
|
|
||
Edema |
1.8 |
2.3 |
1.8 |
|
|
|
|
|
|
|
|
|
|
|||
Cumulative mean values |
|
1.9 |
2.2 |
1.8 |
|
|
|
|
|
|
|
|
|
|
Body weight development
Body weight development in kg |
|||||||||
Administration |
Animal No. |
Sex |
Study day |
Difference |
|||||
1 |
5 |
8 |
11 |
15 |
|||||
Skin |
91012 |
m |
3.40 |
3.45 |
3.55 |
3.55 |
3.66 |
+0.26 |
|
91023 |
f |
3.34 |
3.34 |
3.38 |
3.42 |
3.46 |
+0.12 |
||
91015 |
f |
3.25 |
3.23 |
3.24 |
3.24 |
3.23 |
-0.02 |
||
Mean values |
|
|
3.33 |
3.34 |
3.39 |
3.40 |
3.45 |
+0.12 |
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
- Study period:
- 17-04-1991 to 09-07-1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- OECD 1981, updated Guideline adopted February 24, 1987
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- Iva: NZW
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: SAVO-Ivanovas, Kisslegg
- Age at study initiation: 17 - 19 weeks
- Mean weight at study initiation: 3.40 (3.25 - 3.49) kg
- Housing: cages type KK 017 (floor area: 75 x 54.5 = 4087 cm2, height: 38 cm; manufacturer: Hulskamp) on metal grids
- Diet: Altromin Standard Diet TPFV 2113, pellets from an automatic drinking device ad libitum
- Water: acidified, fully demineralized water from an automatic drinking device ad libitum
- Acclimation period: more than 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 43 - 64
- Photoperiod (hrs dark / hrs light): daylight - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 g test item
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3 animals - 1 male and 2 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: not performed
SCORING SYSTEM: OECD 405 - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.22
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.11
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- other: discharge
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.55
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- other: discharge
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 48 hours
- Irritation parameter:
- other: discharge
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- other: discharge
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- Ocular alterations:
After single instillation of 0.1 g test item into the conjunctival sac of the left eye, without rinsing, no irritation of the cornea and iris was observed. Examination of the conjunctivae revealed redness (score 1), chemosis in 1 animal (score 1), and discharge (score 1 - 2) at the first reading. Later on no irritation was seen. According to these results the test material is not regarded as an irritant. - Other effects:
- Signs of systemic toxicity, body weight, mortality:
No signs of systemic toxicity were seen. The body weight development corresponded to that of untreated rabbits of the same age. All animals survived the 8 day observation period. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- In the primary eye irritation test no irritation of the cornea and iris was observed. The test item is not considered to be irritative.
- Executive summary:
The primary irritation potential of the test item was investigated by instillation of 0.1 g into conjunctival sac of the left eye of each of three young adult New Zealand White rabbits in an OECD 405 study. The right eye remained untreated and served as control. After instillation the eyelids were closed for about 30 seconds. Rinsing of the eyes was not performed. Scoring of irritation effects was performed daily after application for 8 days. After single instillation of 0.1 g test item into the conjunctival sac of the left eye, without rinsing, no irritation of the cornea and iris was observed. Examination of the conjunctivae revealed redness (score 1), chemosis in 1 animal (score 1), and discharge (score 1 - 2) at the first reading. Later on no irritation was seen. According to these results the test material is not regarded as an irritant. No signs of systemic toxicity were seen. The body weight development corresponded to that of untreated rabbits of the same age. All animals survived the 8 day observation period. The average irritation values for conjunctival redness, conjunctival swelling, iritis and clouding of the cornea were 0 in each case. The test item was thus evaluated as not irritating to the eye. No staining of the cornea, sclera or conjunctivae of the treated eyes by the test item was observed. No corrosion was observed at any of the measuring intervals. Based upon the above results, the test item is considered to not be severely irritating to the eye.
Reference
Eye irritation results
|
|
Animal No. |
Sex |
Local findings (study day) |
|||||||
|
|
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
||
I Cornea |
A |
91003 |
m |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
91015 |
f |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
91021 |
f |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
B |
91003 |
m |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
91015 |
f |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
91021 |
f |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
II Iris |
A |
91003 |
m |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
91015 |
f |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
91021 |
f |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
III Conjunctivae |
A |
91003 |
m |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
91015 |
f |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
91021 |
f |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
B |
91003 |
m |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
91015 |
f |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
91021 |
f |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Discharge |
|
91003 |
m |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
91015 |
f |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
91021 |
f |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Cornea A: rating according to OECD 405, B: rating according to Draize method, Iris A: rating according to OECD 405, Conjunctivae A: redness rating according to OECD 405, B: chemosis rating according to OECD 405
Body weight development
Body weight development in kg |
||||||
Administration |
Animal No. |
Sex |
Study day |
Difference |
||
1 |
5 |
8 |
||||
Eye |
91003 |
m |
3.45 |
3.51 |
3.49 |
+0.04 |
91015 |
f |
3.25 |
3.27 |
3.32 |
+0.07 |
|
91021 |
f |
3.49 |
3.58 |
3.61 |
+0.12 |
|
Mean values |
|
|
3.40 |
3.45 |
3.47 |
+0.07 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
OECD 404
The primary skin irritation potential of the test item was investigated by topical application of 0.5 g to skin of the back and sides of each of three young adult New Zealand White rabbits in a OECD 404 study (reference 7.3.1-1). The duration of treatment was four hours. The scoring of skin reactions was performed 1 hour after removal of the dressing and afterwards daily for 14 days. The scores of each animal at the following reading times (24, 48, 72 hours) were used in calculating the respective mean values for each type of lesion. In the primary skin irritation test slight and well-defined erythema (score 1 or 2) and edema were observed on the first days after application, and were followed by necrosis, large scales, and small scales later on, indicating corrosivity of the test material. Though the cumulative mean scores for erythema and edema for days 1, 2, and 3 were not indicative of serious effects, the test material produced corrosive effects on skin contaminated under conditions comparable to those of this test.
OECD 405
The primary irritation potential of the test item was investigated by instillation of 0.1 g into conjunctival sac of the left eye of each of three young adult New Zealand White rabbits in an OECD 405 study (reference 7.3.2-1). The right eye remained untreated and served as control. After instillation the eyelids were closed for about 30 seconds. Rinsing of the eyes was not performed. Scoring of irritation effects was performed daily after application for 8 days. After single instillation of 0.1 g test item into the conjunctival sac of the left eye, without rinsing, no irritation of the cornea and iris was observed. Examination of the conjunctivae revealed redness (score 1), chemosis in 1 animal (score 1), and discharge (score 1 - 2) at the first reading. Later on no irritation was seen. According to these results the test material is not regarded as an irritant. No signs of systemic toxicity were seen. The body weight development corresponded to that of untreated rabbits of the same age. All animals survived the 8 day observation period. The average irritation values for conjunctival redness, conjunctival swelling, iritis and clouding of the cornea were 0 in each case. The test item was thus evaluated as not irritating to the eye. No staining of the cornea, sclera or conjunctivae of the treated eyes by the test item was observed. No corrosion was observed at any of the measuring intervals. Based upon the above results, the test item is considered to not be severely irritating to the eye.
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the substance is classified as corrosive to skin Cat 1 (H314) under Regulation (EC) No 1272/2008, as amended for the twelfth time in Regulation (EU) 2019/521. The substance is not considered to be classified for eye damage/irritation under Regulation (EC) No 1272/2008, as amended for the twelfth time in Regulation (EU) 2019/521.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.