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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
3 - 6 September 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
pentapotassium {[(hydrogen phosphonomethyl)(phosphonomethyl)-oxo-$l^{5}-azanyl]methyl}phosphonate
EC Number:
700-903-6
Cas Number:
255830-15-0
Molecular formula:
C3H7K5NO10P3
IUPAC Name:
pentapotassium {[(hydrogen phosphonomethyl)(phosphonomethyl)-oxo-$l^{5}-azanyl]methyl}phosphonate
Constituent 2
Reference substance name:
ATMP-N-oxide-5K
IUPAC Name:
ATMP-N-oxide-5K
Details on test material:
- Name of test material (as cited in study report): SPE9402

- Physical state: clear colourless liquid

- Storage condition of test material: room temperature

-Other: Reviewers' note: the substance was identified in the study report as the acid form (CAS 15834-10-3), but it is clear that the form of substance to which animals were exposed would have been the potassium salt at pH 11.3.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Regal group UK Ltd., Great Bookham, Surrey, England
- Age at study initiation: 13 weeks
- Weight at study initiation: 3-3.1 kg
- Housing: individually in metal cages with perforated floors.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: yes, however duration unclear

ENVIRONMENTAL CONDITIONS
- Temperature (°C): ca. 19 °C
- Humidity (%): 30-70 %
- Air changes (per hr): ca. 19/hour
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): as supplied
Duration of treatment / exposure:
4 hours
Observation period:
Examination of the treated skin was made on Day 1 (ca. 60 minutes after removal of the dressing) and on Days 2, 3 and 4 (equivalent to 24, 48 and 72 hours after exposure).
Number of animals:
2 females and 1 male
Details on study design:
TEST SITE
- Area of exposure: dorso-lumbar
- Type of wrap if used: Each treatment site was covered with Elastoplast elastic adhesive dressing.

REMOVAL OF TEST SUBSTANCE
- Washing: yes, with warm water. The treated area was then blotted dry with absorbent paper.
- Time after start of exposure: 4 hours

SCORING SYSTEM: Local irritation was assessed using a prescribed numerical system which ran from 0-4 for erythema and for edema, 4 being the most severe reaction.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No dermal response to treatment was observed for any animal throughout the study.
Other effects:
There were no signs of toxicity or ill health in any rabbit during the observation period.

Any other information on results incl. tables

A single semi-occlusive application of SPE9402 to intact rabbit skin for four hours elicited no dermal irritation.

Active acid 19.1%

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
A skin irritation study, conducted in a similar manner to OECD 404 and in compliance with GLP, concluded that ATMP-N-oxide was not irritating to the skin of rabbit.