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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:
27.07.1982 to 03.08.1982
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
[[(phosphonomethyl)imino]bis[ethane-2,1-diylnitrilobis(methylene)]]tetrakisphosphonic acid
EC Number:
239-931-4
EC Name:
[[(phosphonomethyl)imino]bis[ethane-2,1-diylnitrilobis(methylene)]]tetrakisphosphonic acid
Cas Number:
15827-60-8
Molecular formula:
C9H28N3O15P5
IUPAC Name:
{[bis({2-[bis(phosphonomethyl)amino]ethyl})amino]methyl}phosphonic acid
Constituent 2
Reference substance name:
[[(phosphonomethyl)imino]bis[ethane-2,1-diylnitrilobis(methylene)]]tetraki sphosphonic acid
IUPAC Name:
[[(phosphonomethyl)imino]bis[ethane-2,1-diylnitrilobis(methylene)]]tetraki sphosphonic acid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hylyne Rabbits Ltd, Marston, Northwich, Cheshire
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.83 - 3.00 kg
- Housing: Individually in suspended metal cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Minimum of five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ±4
- Humidity (%): 75-80
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: Within the dates 27.07.1982 to 03.08.1982.

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Remarks:
Applied undiluted
Controls:
not required
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
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: Back
- % coverage: Not specified.
- Type of wrap if used: Occlusive patch was held in place with two lengths of sleek adhesive strapping.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: four hours

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: up to 72 hours
Score:
0.5
Max. score:
8
Reversibility:
fully reversible
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:
1
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:
Very slight erythema was observed in two rabbits at the one hour reading; in one animal this was accompanied by very slight oedema. The reaction had ameliorated in one animal by the 24 hour reading but very slight erythema only persisted in the second rabbit until day 7. One animal did not have any reaction at all.
Other effects:
None

Any other information on results incl. tables

ERYTHEMA AND ESCHAR FORMATION
1 hour      1,0,1 (very slight erythema)
24 hours   0,0,1(very slight erythema)
48 hours   0,0,1(very slight erythema)
72 hours   0,0,1(very slight erythema)

OEDEMA FORMATION
1 hour       0,0,1 (very slight oedema)
24, 48, 72 hours   0,0,0

There was no evidence of corrosion in any animal throughout
the test. 

Group total = 6, PDII = 6/12 = 0.5

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In a skin irritation study conducted to GLP and OECD 404 (reliability score 1) Briquest 543-50A (DTPMP acid) was mildly irritating to the skin of two rabbits and not irritating to the skin of one rabbit. The mild irritation was not sufficient to trigger classification.