Registration Dossier
Registration Dossier
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EC number: 931-536-1 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- February 21, 1980 - March 3, 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- No CoA, method used equivalent to OECD 404: 24 hour exposure under occlusive conditions. Intact skin and abraded skin. Skin observed: 24, 72 and 96 hours following test article application and once daily thereafter for a total of 14 days.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Remarks:
- FDA GLP 1979
Test material
- Reference substance name:
- Isopropyl-sec-butylperoxydicarbonate
- EC Number:
- 278-901-5
- EC Name:
- Isopropyl-sec-butylperoxydicarbonate
- Cas Number:
- 78350-78-4
- Molecular formula:
- C9H16O6
- IUPAC Name:
- 2-[({[(propan-2-yloxy)carbonyl]peroxy}carbonyl)oxy]butane
- Reference substance name:
- Bis-sec-butyl peroxydicarbonate
- EC Number:
- 243-424-3
- EC Name:
- Bis-sec-butyl peroxydicarbonate
- Cas Number:
- 19910-65-7
- Molecular formula:
- C10H18O6
- IUPAC Name:
- 2,2'-[dioxybis(carbonyloxy)]dibutane
- Reference substance name:
- Bisisopropyl peroxydicarbonate
- EC Number:
- 203-317-4
- EC Name:
- Bisisopropyl peroxydicarbonate
- Cas Number:
- 105-64-6
- Molecular formula:
- C8H14O6
- IUPAC Name:
- 2,2'-[dioxybis(carbonyloxy)]dipropane
- Test material form:
- liquid
- Details on test material:
- The test article was received, from the Noury Chemical Corporation, Burt, New York on February 14, 1980. It was identified as "Trigonox ADC Peroxydicarbonate liquid" and was received as a clear liquid.
Constituent 1
Constituent 2
Constituent 3
- Specific details on test material used for the study:
- The test article was received, from the Noury Chemical Corporation, Burt, New York on February 14, 1980. It was identified as "Trigonox ADC Peroxydicarbonate liquid" and was received as a clear liquid.
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- SOURCE ANIMAL
- Source: Langshaw Farms, Augusta, Michigan (IRDC Purchase Order #3341)
- Sex: male and female
- Age at study initiation (in days): young adults
- Weight at study initiation: 2204 to 2678 grams
- Housing: individually housed in hanging wire-mesh cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-24
- Humidity (%): 39-48
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: February 21, 1980 - March 3, 1980
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved and abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.5 ml
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 14 days
- Number of animals:
- 3 males and 3 females
- Details on study design:
- TEST SITE
- Area of exposure: back
- % coverage: 6 cm2
- Type of wrap if used: test site of each animal was then covered with gauze bandaging and Saran Wrap® and overwrapped with several layers of Conform® adhesive tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: 24 hours
OBSERVATION TIME POINTS
(indicate if minutes, hours or days) Each test site was observed for skin irritation at 24, 72 and 96 hours following test article application and once daily thereafter for a total of 14 days.
SCORING SYSTEM:
- Method of calculation: Skin Reaction Code, Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, 1977, page 112; modified (inclusion of 0.5 scores) at International Research and Development Corporation.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- other:
- Remarks:
- all animals
- Time point:
- other: 0h, 48h, 72h
- Score:
- >= 1 - <= 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks:
- in one animal
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- other: all animals
- Time point:
- other: 0h, 48h, 72h
- Score:
- >= 0 - <= 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks:
- in one animal
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- See table below:
Any other information on results incl. tables
Erythema
Animal/score at: |
24h* (0h) |
72h* (48h) |
96h* (72h) |
mean |
1m |
2.5 |
1.5 |
1.5 |
1.8 a, b |
2m |
3 |
2 |
2 |
2.3 a |
3m** |
2 |
2 |
2 |
2 |
1f |
3 |
3 |
1.5 |
2.5 a |
2f |
2.5 |
2.5 |
1 |
2 a, b |
3f |
3.0 |
3 |
1.5 |
2.5 a, b |
Oedema
Animal/score at: |
24h* (0h) |
72h* (48h) |
96h* (72h) |
mean |
1m |
2.5 |
1.5 |
0.5 |
1.5 |
2m |
3 |
1.5 |
1 |
1.8 |
3m** |
2.5 |
2.0 |
2 |
2.2 |
1f |
2.5 |
1.5 |
0.5 |
1.5 |
2f |
3 |
0.5 |
0 |
1.2 |
3f |
2.5 |
1 |
1.5 |
1.7 |
* following test article application, instead of24, 48 and 72 hours after patch removal.
** very slight oedema and erythema observed after 14 days
a Desquamation present at day 14.
b Fissuring present at day 14
None of the animals died, 2 males and 2 females had diarrhea (M 2( 1), 1( 2), 2(3), 1(4), 2(5), 1(6 -8), 2(11 -14)) and F (2(11-12), 3(13-14)). One of these males had nasal discharge 1(6 -14) and soft stool 1(1). The animals had a decreased body weight at study termination.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- CLP criteria 1 for classifying Catergory 2 is met:
(1) Mean value of ≥ 2,3 - ≤ 4,0 for erythema/ eschar or for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after patch removal or, if reactions are delayed, from grades on 3 consecutive days after the onset of skin reactions; or
(2) Inflammation that persists to the end of the observation period normally 14 days in at least 2 animals, particularly taking into account alopecia (limited area), hyperkeratosis, hyperplasia, and scaling; or
(3) In some cases where there is pronounced variability of response among animals, with very definite positive effects related to chemical exposure in a single animal but less than the criteria above. - Executive summary:
CLP criteria 1 for classifying Catergory 2 is met
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