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Toxicological information

Skin irritation / corrosion

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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:
1993
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

Constituent 1
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

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