Registration Dossier
Registration Dossier
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EC number: 221-110-7 | CAS number: 3006-82-4
Skin irritation / corrosion
Administrative data
- 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:
- test procedure in accordance with national standard methods with acceptable restrictions
- Remarks:
- No Guideline stated, no GLP statement available, more stringent test conditions as requires in OECD guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- more stringed test conditions
- Principles of method if other than guideline:
- NA
- GLP compliance:
- not specified
Test material
- Reference substance name:
- tert-butyl 2-ethylperoxyhexanoate
- EC Number:
- 221-110-7
- EC Name:
- tert-butyl 2-ethylperoxyhexanoate
- Cas Number:
- 3006-82-4
- Molecular formula:
- C12H24O3
- IUPAC Name:
- tert-butyl 2-ethylhexaneperoxoate
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
Source: Kuiper's Rabbit Ranch, Gary, Indiana
Housing: rabbits were individually housed in hanging wire-mesh cages in temperature and humidity controlled quarters
Conditioning period: 6 days prior to study initiation
Diet: ad libitum
Water: ad libitum
Body weights prior to administration: 2010 to 2770 g
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: 3 animals clipped and 3 animals abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL - Duration of treatment / exposure:
- 24 hrs
- Observation period:
- 24 and 72 hrs after application
- Number of animals:
- 6 (3 male, 3 female)
- Details on study design:
- TEST SITE
- Area of exposure: back of each rabbit
- % coverage: 20 - 30 % of the body surface
- Type of wrap if used: the application sites were covered with gauze bandaging and overwrapped with Saran Wrap. The entire application area was then wrapped with several layers of 75 mm Elastoplast tape. A collar was also applied.
REMOVAL OF TEST SUBSTANCE
- Washing: the sites were washed with tepid tap water
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- 33229/M
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: intact skin
- Remarks:
- 48 h were not assessed
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- 33198/F
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: intact skin
- Remarks:
- 48 h were not assessed
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- 33216/F
- Time point:
- 24/48/72 h
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: intact skin
- Remarks:
- 48 h were not assessed
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.8
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: intact skin
- Remarks:
- 48 h were not assessed
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- 33229/M
- Time point:
- 24/48/72 h
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: intact skin
- Remarks:
- 48 h were not assessed
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- 33198/F
- Time point:
- 24/48/72 h
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: intact skin
- Remarks:
- 48 h were not assessed
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- 33216/F
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: intact skin
- Remarks:
- 48 h were not assessed
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.2
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: intact skin
- Remarks:
- 48 h were not assessed
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- 33197/M
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: abraded skin
- Remarks:
- 48 h were not assessed
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- 33225/M
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: abraded skin
- Remarks:
- 48 h were not assessed
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- 33192/F
- Time point:
- 24/48/72 h
- Score:
- 1.75
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: abraded skin
- Remarks:
- 48 h were not assessed
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.9
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: abraded skin
- Remarks:
- 48 h were not assessed
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- 33197/M
- Time point:
- 24/48/72 h
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: abraded skin
- Remarks:
- 48 h were not assessed
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- 33225/M
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: abraded skin
- Remarks:
- 48 h were not assessed
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- 33192/F
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: abraded skin
- Remarks:
- 48 h were not assessed
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.25
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: abraded skin
- Remarks:
- 48 h were not assessed
- Irritant / corrosive response data:
- NA
- Other effects:
- NA
Any other information on results incl. tables
No remarks
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Following study results and the OECD GHS (1272/2008) criteria, tert.-Butylperoxy- 2-ethylhexanoat is not considered as an primary skin irritant. With regard to Commission Directive 67/548 the results represents a borderline case.
- Executive summary:
Tert.-Butylperoxy- 2-ethylhexanoat was tested to three male and 3 female New Zealand White rabbits similar to OECD guideline 404 (but more stringed test conditions). The hair was removed from the back of each rabbit. (20 - 30 % of the body surface) with an electric clipper. The skin of 3 of the rabbits was abraded with a scalpel blade. The abrasion penetrated the stratum corneum, but were not deep enough to cause bleeding.
A volume of 0.5 mL of the test material was applied to the back of each rabbit under a one inch square gauze patch. The application sites were covered with gauze bandaging and overwrapped with Saran Wrap. The entire application area was then wrapped with several layers of 75 mm Elastoplast tape. A collar was also applied. Following 24 hours of application, the bandages and collars were removed and the sites were washed with tepid tap water and examined for skin irritation. The examinations were repeated at 72 hours.
The table below presents the grade of effect with time.
Intact skin
Abraded Skin
Observations
Value
24 hrs
72 hrs
24 hrs
72 hrs
Erythema, Eschar Formation
0
1/3
1/3
1
1/3
1/3
1/3
2
2/3
2/3
1/3
2/3
3
4
Oedema Formation
0
1/3
1/3
1/3
1
2/3
1/3
2/3
1/3
2
2/3
1/3
3
4
Calculation for Primary Skin Irritation Score (Score = The average of all the erythma scores plus the average of all the oedema scores): (18.5 ÷ 12) + (12 ÷ 12) = 2.5.
In this study, the test conditions were more stringed as required in OECD guidelines and can thus be regarded as worst case scenario.
The conditions in this study were 24 hours occlusive treatment, whereas in the OECD guideline 4 hours semi-occlusive treatment is requested.
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