Registration Dossier
Registration Dossier
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EC number: 202-653-9 | CAS number: 98-29-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 16 February 1987 to 27 May 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to a recognised guideline and under GLP conditions. However, the purity of the test substance is not specified.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4-tert-butylpyrocatechol
- EC Number:
- 202-653-9
- EC Name:
- 4-tert-butylpyrocatechol
- Cas Number:
- 98-29-3
- Molecular formula:
- C10H14O2
- IUPAC Name:
- 4-tert-butylbenzene-1,2-diol
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Hybrid Albino New-Zealand
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Strain: Hybrid Albino New-Zealand
- Sex: males
- Sources: *Charles River: Saint Aubin Les Elbeuf - 76410 Cléon - France
*E.G.A.V: Saint Mars d'Egrenne - 61350 Passais La Conception - France
*E.S.D: Roman - 01400 Châtillon sur Chalaronne - France
- Age at study initiation: no data
- Weight at study initiation: 2.5 +/- 0.2 kg
- Housing: individual housing, in polystyrene cages, of internal dimensions 560x355x315 mm, with a perforated floor
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: one week
ENVIRONMENTAL CONDITIONS
- Temperature: 20 +/- 3°C
- Humidity: 30 to 70%
- Air changes: no data
- Photoperiod: 12 hrs dark / 12 hrs light
IN-LIFE DATES: From: 3 March 1987 To: 17 March 1987
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- Concentration: 0.5 mL undiluted
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: a surface of about 6 cm2
- % coverage: no data
- Type of wrap: a Codex hydrophilic eight layer gauze pad
REMOVAL OF TEST SUBSTANCE
- Washing: the bandages were removed and if necessary excess test substance which had not penetrated was wiped away with a gauze pad moistened with distilled water
- Time after start of exposure: 4 hours
SCORING SYSTEM: based on erythema and oedema formation, according to directive OECD 404
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: aspect of burn on all the zone of application
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3.34
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: see table of results
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 3.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 3.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
Any other information on results incl. tables
Erythema:
animal |
mean 24/48/72 hours |
| n°1 | 4.00 |
| n°2 | 4.00 |
| n°3 | 4.00 |
| n°4 | 4.00 |
| n°5 | 4.00 |
| n°6 | 4.00 |
| mean | 4.00 |
After 14 days: mean = 4.00 for all animals + presence of eschars on all the zone of application
Oedema:
animal |
mean 24/48/72 hours |
| n°1 | 3.67 |
| n°2 | 2.67 |
| n°3 | 3.67 |
| n°4 | 3.67 |
| n°5 | 3.00 |
| n°6 | 3.33 |
| mean | 3.34 |
After 14 days: mean = 0.00 for all animals
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (corrosive) based on GHS criteria
- Conclusions:
- 4-tert-butylpyrocatechol 85% in water is classified as :
- Skin corrosive category 1B according to UN/EU GHS classification criteria - Executive summary:
In a dermal irritation study (Hazleton, 1987), hybrid albino New-Zealand White rabbits (6 males) were dermally exposed to 0.5 mL of 4 -tert-butylpyrocatechol 85% in water on a 6 cm2 body surface area. Test sites were covered with a semi-occlusive dressing for 4 hours. Animals were then observed for 14 days. Irritation was scored by the method of directive OECD 404.
After 1 hour of exposure, severe erythema and moderate (1/6 rabbits) or severe (5/6 rabbits) oedema were observed in all treated animals. Severe erythema was not reversible after 14 days and oedema was fully reversible within 14 days. In this study, 4 -tert-butylpyrocatechol 85% in water was corrosive to the skin based on the observed skin reactions.
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