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EC number: 201-557-4 | CAS number: 84-74-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (GLP; QAU)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 84-74-5
- IUPAC Name:
- 84-74-5
- Reference substance name:
- Dibutyl phthalate
- EC Number:
- 201-557-4
- EC Name:
- Dibutyl phthalate
- Cas Number:
- 84-74-2
- Molecular formula:
- C16H22O4
- IUPAC Name:
- dibutyl phthalate
- Details on test material:
- - Physical state: liquid, clear, achromatic
- Analytical purity: 99,4%
- Lot/batch No.: P. 66 A/89
- Stability under test conditions: on completion of all tests, the stability of the substance was verified by a repeated analysis
- Storage condition of test material: at room temperature
- Other: the sample appeared to be homogeneous
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: White Vienna animals from Gaukler; D-6050 Offenbach/Main, FRG
- Age at study initiation: young adult animals
- Weight at study initiation: mean bw of 2.71 kg for males (2) and 2.51 kg for female (1)
- Housing: one animal per cage in cages made of stainless steel with wire mesh walk floors (floor area : 40 cm x 51 cm)
- Diet (e.g. ad libitum): Kliba 341, 4 MM; from Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland (about 130 g per animal per day)
- Water (e.g. ad libitum): about 250 ml tap water per animal per day
- Acclimation period: at least 8 days before the beginning of the study
ENVIRONMENTAL CONDITIONS
The animals were housed in fully air-conditioned rooms. Central air-conditioning guaranteed a temperature range and a relative humidity. There were no deviations from these ranges which influenced the results of the study.
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin site of the same animals
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml - Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- 72 hours (all irritation effects were reversible within 48 hours)
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: upper third of the back or flanks; the fur was clipped at least 15 hours before the beginning of the study
- % coverage: . application site of 2.5 x 2.5 cm was covered with the 0.5 ml (526 mg) test substance
- Type of wrap if used: semiocclusive patch
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with lutrol and lutrol/water 1:1
- Time after start of exposure: at the end of exposure period (4 hours)
SCORING SYSTEM: OECD scoring system
Readings: 30 - 60 min, and 24, 48, or 72 hours after removal of test patches
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of all tested animals (3)
- Time point:
- other: 24-48-72-hour
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of all tested animals (3)
- Time point:
- other: 24-48-72-hour
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: no edema observed at any time point
- Irritant / corrosive response data:
- After 4 and 24 hours very slight (grade 1) erythema were obeserved for 2/3 animals. They were completely reversible within after 48 hours (see Table 1).
- Other effects:
- None observed
Any other information on results incl. tables
Table 1: Results acute skin irritation/corrosivity (OECD scores)
Test animal |
After 30-60 min |
After 24 hours |
Âfter 48 hours |
After 72 hours |
Mean 24-48-72-hour |
|||||
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
|
1 |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0.3 |
0.0 |
2 |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0.3 |
0.0 |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
Mean |
0.67 |
0 |
0.67 |
0 |
0 |
0 |
0 |
0 |
0.2 |
0.0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: EU GHS
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