Trizinc dicitrate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

from 7 Nov 1994 to 10 Nov 1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study was conducted according to the appropriate OECD test guideline and in compliance with GLP. The study is read across from trisodium citrate (CAS 68-04-2).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Trisodium citrate

EC Number:

200-675-3

EC Name:

Trisodium citrate

Cas Number:

68-04-2

Molecular formula:

C6H8O7.3Na

IUPAC Name:

trisodium citrate

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, Stolzenseeweg 32-36, D-88353 Kisslegg, GERMANY
- Age at study initiation: 15 wk
- Weight at study initiation (kg): 2.9 (male); 2.5, 2.8 (females)
- Housing: 1/stainless steel cage
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 h/12 h

IN-LIFE DATES: From: 7 Nov 1994 To: 10 Nov 1994

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g (moistened with distilled water)

VEHICLE
- Amount(s) applied: sufficient to moisten

Duration of treatment / exposure:

4 h

Observation period:

1, 24, 48 72 h

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 6 cm2
- % coverage: not stated
- Type of wrap if used: surgical gauze; semi-occlusive dressing; elastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): test substance removed with warm water.
- Time after start of exposure: 4 h

SCORING SYSTEM: grading according to OECD 404; scoring mean of 24, 48 and 72 h readings

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: 24, 48, 72 h mean

Score:

0.11

Max. score:

8

Reversibility:

fully reversible within: 48 h

Irritant / corrosive response data:

See table 1.

Other effects:

None.

Any other information on results incl. tables

Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility	Erythema	Edema
	Max. score: 4	Max. score: 4
1 h	0/0/0	0/0/1
24 h	0/0/0	0/0/1
48 h	0/0/0	0/0/0
72 h	0/0/0	0/0/0
Average 24h, 48h, 72h	0/0/0	0/0/0.33
Reversibility*	-	c
Average time (unit) for reversion	-	Within 48 h

·         Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

Overall mean score (3 animals; 24, 48, 72 h) = 0.11/8

 

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

A reliable study conducted in accordance with OECD 404 and GLP, found the test material to be transiently mildly irritating to the skin of rabbits. The report describes the material as non irritant according to EC criteria; current EC criteria would concur with this finding. The result is read across from trisodium citrate (CAS 68-04-2).