Registration Dossier
Registration Dossier
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EC number: 306-227-4 | CAS number: 96690-34-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 18 May - 01 June 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 28 July 2015
- Deviations:
- yes
- Remarks:
- occlusive coverage
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Umweltministerium Baden-Württemberg, Stuttgart, Germany
Test material
- Reference substance name:
- Amines, C12-14-tert-alkyl, mixed sec-Bu and iso-Bu phosphates
- EC Number:
- 306-227-4
- EC Name:
- Amines, C12-14-tert-alkyl, mixed sec-Bu and iso-Bu phosphates
- Cas Number:
- 96690-34-5
- Molecular formula:
- C4H11O4P to C8H20O7P2 as representative molecular formula of the composition as specified in section 1.2
- IUPAC Name:
- Amines, C12-14-tert-alkyl, mixed sec-Bu and iso-Bu phosphates
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: albino
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. Zimmermann, Untergröningen/Aalen, Germany
- Weight at study initiation: 2988 - 3090 g
- Housing: rabbits were housed individually in wire grating cages (area: 2450 cm², height: 42 cm) without bedding.
- Diet: Raiffeisen-Ringfutter, Kaninchen Trockenfutter 52/P (Raiffeisen Kraftfutterwerk Kehl, Germany), ad libitum
- Water: community tap water from Karlsruhe (Germany), ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 22
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated shaved area close to the exposure area served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- 14 days
Reading time points: 1, 24, 48 and 72 h, Days 6 - 10, Day 12 and Day 14 - Number of animals:
- 3 (2 males and 1 female)
- Details on study design:
- TEST SITE
- Area of exposure: dorsolumbar area of the trunk (3 x 5 cm² on the trunk were shaved before treatment)
- Type of wrap if used: the treated region was protected with gauze and with an occlusive bandage.
REMOVAL OF TEST SUBSTANCE
- Washing: residual test substance was removed by gently washing with water.
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritant / corrosive response data:
- At the 1 h reading time point, very slight (1/3 animals, score 1) to well-defined erythema (2/3 animals, score 2) were observed. At the same time point, 2 animals showed very slight edema (score 1), whereas 1 animal showed moderate edema (score 3). Well-defined erythema (score 2) and very slight edema (score 1) were observed in all animals at the 24, 48 and 72 h reading time point after exposure of the test substance. In all animals, edema were fully reversible within 6 days after application, whereas very slight erythema (score 1) were still evident in all animals at the end of the 14-day observation period.
- Other effects:
- No further local or systemic effects were observed.
Any other information on results incl. tables
Table 1: Results of skin irritation study
| Observation time | Rabbit no. | |||||
| 1 | 2 | 3 | ||||
| Erythema | Edema | Erythema | Edema | Erythema | Edema | |
| 1 h | 1 | 1 | 2 | 1 | 2 | 3 |
| 24 h | 2 | 1 | 2 | 1 | 2 | 2 |
| 48 h | 2 | 1 | 2 | 1 | 2 | 1 |
| 72 h | 2 | 1 | 2 | 1 | 2 | 0 |
| Mean value 24 + 48 + 72 h | 2,00 | 1,00 | 2,00 | 1,00 | 2,00 | 1,00 |
Applicant's summary and conclusion
- Interpretation of results:
- other: Skin Irrit. 2, H315 according to Regulation (EC) No 1272/2008
- Conclusions:
- CLP: Cat. 2, H315
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