Registration Dossier
Registration Dossier
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EC number: 251-073-2 | CAS number: 32509-66-3
Endpoint summary
Administrative data
Description of key information
Skin irritation was tested in a guideline study according to OECD guideline 404 in 6 Himalyan rabbits. With reference the reported scores and the reported trend to decreasing severity of effects within 72 h Hostanox O 3 does not have to be classified as irritant to the skin.
Ethylene-bis[3,3-bis(3-tert.-butyl-4-hydroxyphenyl)butyrate] was tested for its eye irritant properties in 6 Albino-Himalayan rabbits. The study was performed according to OECD Guideline 405. Effects on conjunctivae (redness and swelling) were observed in all animals one hour after application. These signs decreased significantly within 72 hours and full reversibility is assumed occur after 14 days recovery.
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:
- 3 Mar - 6 Mar 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study performed in analogy to current OECD guideline.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- 24 h exposure, 72 h observation period
- Qualifier:
- according to guideline
- Guideline:
- other: according to method: §1500.41 Federal register 38, No. 187, 27.09.1973, p 27019.
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- performed before GLP guidelines
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG own breed (Hoe:HIMK (SPFWiga)
- Weight at study initiation: 1.9-2.3 kg
- Housing: single cages
- Diet (e.g. ad libitum): ERKA 8300 (Futtermittelwerk Robert Koch oHG, Hamm/Westf.) ad libitum
- Water (e.g. ad libitum): ad libitum
IN-LIFE DATES: From: 3 March To: 6 March 1980 - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- other: moistened with sesame oil (test no.1) or PEG 400 (test no.2)
- Controls:
- not required
- Amount / concentration applied:
- Two tests each performed with 500 mg Hostonx O 3
- Duration of treatment / exposure:
- 24 h
- Observation period:
- 24 hours post application
48 hours post application
72 hours post application - Number of animals:
- Two tests performed with 6 rabbits each
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: 100 %
The substance was applied over the whole surface of a 2.5 x 2.5 cm cellulose patch on a piece of surgical plaster (Hansamed). The plaster was fixed to the prepared skinarea (ca. 18 cm2) and then covered with a occlusive polyethylene foil and further fixed with an elastic bandage.
SCORING SYSTEM:
Erythema and eschar formation
No erythema.......................................................................................................................0
very slight erythema (barely perceptible)......................................................................1
well-defined erythema......................................................................................................2
moderate to severe erythema..........................................................................................3
severe erythema (beet redness) to slight eschar formation (lesion in depth).........4
Oedema
No oedema...................................................................................................................................0
very slight oedema (barely perceptible)..................................................................................1
slight oedema (edges of area well defined by definite raising)............................................2
moderate oedema (raised approximately 1mm)....................................................................3
severe oedema (raised more than 1mm and extending beyond area of exposure.........4 - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 2
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 1
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- all 1- 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0.8
- Max. score:
- 2
- Irritation parameter:
- erythema score
- Basis:
- animal: 7; mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal: 8; mean
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Irritation parameter:
- erythema score
- Basis:
- animal: 9; mean
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 1
- Irritation parameter:
- erythema score
- Basis:
- animal: 10; mean
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 1
- Irritation parameter:
- erythema score
- Basis:
- animal: 11; mean
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 2
- Irritation parameter:
- erythema score
- Basis:
- animal: 12; mean
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 2
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- all 7-12 animals
- Time point:
- 24/48/72 h
- Score:
- 0.8
- Max. score:
- 2
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 2
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- all 1-6 animals
- Time point:
- 24/48/72 h
- Score:
- 0.17
- Max. score:
- 2
- Irritation parameter:
- edema score
- Basis:
- animal: 7; mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal: 8; mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal: 9; mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal: 10; mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal: 11; mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal: 12; mean
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 1
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- all 7-12 animals
- Time point:
- 24/48/72 h
- Score:
- 0.1
- Max. score:
- 1
- Irritant / corrosive response data:
- Test 1 in sesame oil (animal number 1-6):
Erythema score: mean all 6 animals (24, 48, 72h): 0.8
Edema score: mean all 6 animals (24, 48, 72h): 0.17
Test 2 in PEG 400 (animal number 7-12):
Erythema score: mean all 6 animals (24, 48, 72h): 0.8
Edema score: mean all 6 animals (24, 48, 72h): 0.1 - Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- With reference the reported scores and the reported trend to decreasing severity of effects within 72 h Hostanox O 3 does not have to be classified as irritant to the skin according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).
- Executive summary:
Hostanox O 3 was tested for its skin irritant properties in 6 Himalayan rabbits. The study was performed according to OECD Guideline 404. Deviations were the absence of the recovery period of 14 days and a prolonged exposure period (24 hours). These conditions make the study design more rigid compared to the regarding OECD Guideline.
With reference the reported scores and the reported trend to decreasing severity of effects within 72 h Hostanox O 3 does not have to be classified as irritant to the skin according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).
Reference
1. Irritation scores (Vehicle: Sesame oil)
Time post appl. |
24 h |
48 h |
72 h |
|||||||||||||||
Animal number |
1 |
2 |
3 |
4 |
5 |
6 |
1 |
2 |
3 |
4 |
5 |
6 |
1 |
2 |
3 |
4 |
5 |
6 |
Erythema score |
2 |
2 |
1 |
0 |
0 |
1 |
2 |
2 |
1 |
0 |
1 |
0 |
1 |
2 |
0 |
0 |
0 |
0 |
Oedema score |
0 |
2 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2. Irritation scores (Vehicle: PEG 400)
Time post appl. |
24 h |
48 h |
72 h |
|||||||||||||||
Animal number |
7 |
8 |
9 |
10 |
11 |
12 |
7 |
8 |
9 |
10 |
11 |
12 |
7 |
8 |
9 |
10 |
11 |
12 |
Erythema score |
0 |
0 |
0 |
0 |
2 |
1 |
0 |
1 |
1 |
1 |
2 |
2 |
0 |
0 |
1 |
1 |
1 |
2 |
Oedema score |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
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
- Study period:
- 3 Mar - 6 Mar 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Methods applied similar to OECD405
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- no recovery period, scoring according to FDA
- Qualifier:
- according to guideline
- Guideline:
- other: FDA Guideline, Register 38 No. 187, 27.09.1973, p 27019
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- study performed before GLP guidelines
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG own breed (Hoe:HIMK (SPFWiga)
- Weight at study initiation: 1.9-2.3 kg
- Housing: single cages
- Diet (e.g. ad libitum): ERKA 8300 (Futtermittelwerk Robert Koch oHG, Hamm/Westf.) ad libitum
- Water (e.g. ad libitum): ad libitum
IN-LIFE DATES: From: 3 March To: 6 March 1980 - Vehicle:
- other: moistened by sesame oil or 0.1 mL PEG 400
- Controls:
- not required
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 1, 7, 24, 48and 72 hours after application
- Number of animals or in vitro replicates:
- 6 animals (no. 1 - 6) for moistening with sesame oil
6 animals (no. 7-12) for moistening with PEG 400 - Details on study design:
- The eyes were examined 1, 7, 24, 48 and 72 hours after application of the test substance.
24 hours after treatment the eyes were washed out with physological saline.
At 48 and 72 hours the eyes were also examined after instillation of one drop of 0.01 % fluorescein-sodium solution.
SCORING SYSTEM:
A. CORNEA
Degree of opacity (most dense area used)
No opacity ...................................................................................................................0
Scattered or diffuse areas, details of iris clearly visible........................................1
Easily discernible translucent areas, details of iris slightly obscured................2
Opalescent areas, no details of iris visible , size of pupil barely discernible ....3
Opaque, iris invisible, ulzeration ..............................................................................4
B. Affected area
1 = punctiform up to 1/4 but not 0
2 = more than 1/4 up to 1/2
3 = more than 1/2 up to 3/4
4 = more than 3/4 up t o 4/4
a = A x B x 5 (max 80)
IRIS
Normal ......................................................................................................................... 0
Folds above normal , congestion, swelling, circumcorneal injection (any of all of these or combination of any thereof); iris still reacting to light
(sluggish reaction is positive) ......................... .........................................................1
No reaction to light, haemorrhage, gross destruction (any or all of these) ......2
b = Value x 5 (max. 10)
CONJUNCTIVAE
A. Redness
Blood vessels normal...............................................................................................................0
Blood vessels definitely injected above normal ................................................................. 1
More diffuse, deeper crimson red, individual blood vessels not easily discernible .....2
Diffuse beefy red......................................................................................................................3
B. Chemosi s (refers to palpebral and bulbar conjunctivae)
No swelling .........................................................................................0
Any swelling above normal (includes nictitating membran) ..... 1
Obvious swelling with partial eversion of l i d s ...........................2
Swelling with lids about half closed ................................................3
Swelling with lids half closed to completely closed.......................4
C. Secretion
No secretion......................................................................................................................0
Any secretion above normal...........................................................................................1
Secretion with wetting of palpebra and hair close to palpebra.................................2
Secretion with wetting of palpebra, hair and considerable area around eyes........3
c = (A+B+C) x 2 (max. 20)
For each animal the ratings for cornea (a), iris (b) and conjunctivae (c) were added for the respective time of observation. For each time of observation the mean value was calculated for all animals. The highest determined irritation score for any time of observation was used for classification according following evaluation classes:
0-10..........non irritant
11-25.......slightly irritant
26-56.......moderately irritant
57-110.....severely irritant - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animals 1-6
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effects observed
- Remarks:
- Individual scores are provided in tabular (refer to "Any other information on results incl. tables")
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animals 7-12
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effects observed
- Remarks:
- Individual scores are provided in tabular (refer to "Any other information on results incl. tables")
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal 1-6
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effects observed
- Remarks:
- Individual scores are provided in tabular (refer to "Any other information on results incl. tables")
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal 7-12
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effects observed
- Remarks:
- Individual scores are provided in tabular (refer to "Any other information on results incl. tables")
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal 1-6
- Time point:
- other: 24, 48, 72 h
- Score:
- 1.4
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72 h
- Remarks:
- 3 rabbits out of 6 had decreasing score of 1 or 2
- Remarks on result:
- other: Methodically not longer observed, but full reversibility is expected after 14 days.
- Remarks:
- Individual scores are provided in tabular (refer to "Any other information on results incl. tables")
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal 7-12
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 72 h
- Remarks:
- 3 rabbits out of 6 had decreasing score of 1
- Remarks on result:
- other: Methodically not longer observed, but full reversibility is expected after 14 days.
- Remarks:
- Individual scores are provided in tabular (refer to "Any other information on results incl. tables")
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal 1-6
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 72h
- Remarks:
- 1 rabbit out of 6 had a score of 1
- Remarks on result:
- other: Methodically not longer observed, but full reversibility is expected after 14 days.
- Remarks:
- Individual scores are provided in tabular (refer to "Any other information on results incl. tables")
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal 7-12
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 72 h
- Remarks:
- 1 rabbit out of 6 had a score of 1
- Remarks on result:
- other: Methodically not longer observed, but full reversibility is expected after 14 days.
- Remarks:
- Individual scores are provided in tabular (refer to "Any other information on results incl. tables")
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- With reference the reported scores and the reported trend to decreasing severity of effects within 72 h Hostanox O 3 does not have to be classified as irritant to the eyes according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).
- Executive summary:
Hostanox O 3 was tested for its eye irritant properties in 6 Albino-Himalayan rabbits. The study was performed according to OECD Guideline 405. The only deviation was the absence of the recovery period of 14 days.
Effects on conjunctivae (redness and swelling) were observed in all animals one hour after application. These signs decreased significantly within 72 hours and full reversibility is assumed occur after 14 days recovery.
With reference the reported scores and the reported trend to decreasing severity of effects within 72 h Hostanox O 3 does not have to be classified as irritant to the eyes according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).
Reference
1. Irritation scores (Vehicle: Sesame oil)
Time post appl. |
24 h |
48 h |
72 h |
|||||||||||||||
Animal number |
1 |
2 |
3 |
4 |
5 |
6 |
1 |
2 |
3 |
4 |
5 |
6 |
1 |
2 |
3 |
4 |
5 |
6 |
Cornea score |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Iris score |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Conjunctivae score |
2 |
2 |
3 |
3 |
2 |
2 |
1 |
1 |
2 |
2 |
1 |
1 |
1 |
0 |
2 |
1 |
0 |
0 |
Chemosis sore |
1 |
1 |
2 |
2 |
1 |
1 |
0 |
0 |
2 |
1 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
2. Irritation scores (Vehicle: PEG 400)
Time post appl. |
24 h |
48 h |
72 h |
|||||||||||||||
Animal number |
7 |
8 |
9 |
10 |
11 |
12 |
7 |
8 |
9 |
10 |
11 |
12 |
7 |
8 |
9 |
10 |
11 |
12 |
Cornea score |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Iris score |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Conjunctivae score |
2 |
1 |
1 |
1 |
1 |
1 |
2 |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
1 |
0 |
1 |
1 |
Chemosis sore |
0 |
1 |
1 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation: 1 key study available: not irritating
Eye irritation: 1 key study available: not irritating
There is one reliable study on the skin irritancy potential. Skin irritation was tested in a guideline study according to OECD guideline 404 in 6 Himalyan rabbits. With reference the reported scores and the reported trend to decreasing severity of effects within 72 h Hostanox O 3 does not have to be classified as irritant to the skin.
There is one reliable study available on the eye irritancy potential. Ethylene-bis[3,3-bis(3-tert.-butyl-4-hydroxyphenyl)butyrate]was tested for its eye irritant properties in 6 Albino-Himalayan rabbits. The study was performed according to OECD Guideline 405.
Effects on conjunctivae (redness and swelling) were observed in all animals one hour after application. These signs decreased significantly within 72 hours and full reversibility is assumed occur after 14 days recovery.
Justification for selection of skin irritation / corrosion endpoint:
Study performed in analogy to current OECD guideline.
Justification for selection of eye irritation endpoint:
Methods applied similar to OECD405
Justification for classification or non-classification
With reference the reported scores and the reported trend to decreasing severity of effects within 72 h Ethylene-bis[3,3-bis(3-tert.-butyl-4-hydroxyphenyl)butyrate] does not have to be classified as irritant to the akin and eyes according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).
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.
