Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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:
From 19 January 1989 to 27 april 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Tetrakis(hydroxymethyl)phosphonium chloride
EC Number:
204-707-7
EC Name:
Tetrakis(hydroxymethyl)phosphonium chloride
Cas Number:
124-64-1
Molecular formula:
C4H12O4P.Cl
IUPAC Name:
tetrakis(hydroxymethyl)phosphonium chloride

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Froxfield Farms (U.K.) Ltd., Petersfield, Hampshire, England.
- Age at study initiation: 9 to 11 weeks
- Weight at study initiation: 2.1 to 2.5 kg
- Housing: individually housed in metal cages with perforated floors.
- Diet: ad libitum, SDS standard Rabbit diet.
- Water: ad libitum, tap water.
- Acclimation period: Animals acclimated, period not specified


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19
- Humidity (%): 30-70
- Air changes (per hr): 19
- Photoperiod: 12 hrs dark / 12 hrs light (7h - 19h)


IN-LIFE DATES: From: 24 January 1989 to 7 February 1989

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): 80 %


Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 10 cm²
- Type of wrap if used: gauze pad, each treatment site was occluded with "Elastoplast" elastic adhesive dressing.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treatment site was washed using water to remove any residual test substance
- Time after start of exposure: 4 hours

SCORING SYSTEM: similar to draize scale.

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 reversible
Remarks:
after 14 days, with necrotic lesions.
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable.
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable.
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable.
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
1.66
Max. score:
4
Reversibility:
not fully reversible within: 14 days.
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 14 days.
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable.
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable.
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable.
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable.
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
1.66
Max. score:
4
Reversibility:
not fully reversible within: 14 days.
Irritant / corrosive response data:
Focal necrotic areas accompanied by well-defined erythema and slight oedema had developed in two animals by Day 2 or 3. These lesions were still present on Day 14.
Very slight erythema and oedema was observed on Day 1 only, in the remaining four animals.
Other effects:
None was reported.

Any other information on results incl. tables

Table 1: Irritant/corosive response data for each female/male animal after 4h exposure under semiocclusive coverage

 

score at time point/ Reversibility

Erythema
Max. score:4

Edema
Max. score:4

 30 min

 1/1/1/1/1/1 

 1/0/0/0/0/1 

 24h

 2*/0/0/0/0/1*

 2/0/0/0/0/1

 48h

 2*/0/0/0/0/2*

 2/0/0/0/0/2

 72h

 2*/0/0/0/0/2*

 2/0/0/0/0/2

 day 14

2*/0/0/0/0/2*

2/0/0/0/0/2

 Average 24h, 48h, 72h

0.6

0.6

 Reversibility after 14 days

n.c.

n.c.

*Focal necrotic lesion

Reversibility: n.c.= not completely reversible

The considerable variation in degree of response in this study was unusual and cannot readily be explained. The necrotic lesions were small and were similar to lesions observed in the acute dermal toxicity study (HRC Report no. 89215D/ A&W 497/AC).

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this test, THPC was classified corrosive category 1C according to regulation (EC) 1272/2008.
Executive summary:

In a primary dermal irritation study (Liggett, 1989), male and female New Zealand white rabbit (3 per sex) were dermally exposed to 0.5 ml de THPC for 4 hours to an area of skin approximately 10 cm² (dorso-lumbar region). Test sites were covered with a semi-occlusive dressing for 4 hours. At the end of the exposure period, the semi-occlusive dressing and gauze pad were removed and the treatment site was washed using water to remove any residual test substance. Animals then were observed for 14 days.

Irritation was scored by a numerical scoring system similar to Draize scale. Focal necrotic areas accompanied by well-defined erythema and slight oedema had developed in two animals by Day 2 or 3. These lesions were still present on Day 14. Very slight erythema and oedema was observed on Day 1 only, in the remaining four animals.

In this study, THPC is considered as corrosive to the skin based on the EC/67/548 classification criteria.