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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
7-10 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.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

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

Constituent 1
Chemical structure
Reference substance name:
Sodium dihydrogen citrate
EC Number:
242-734-6
EC Name:
Sodium dihydrogen citrate
Cas Number:
18996-35-5
Molecular formula:
C6H8O7.Na
IUPAC Name:
dihydrogen sodium 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): 3.0 (male), 2.7-2.9 (females)
- Housing: 1/stainles 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: 1994-11-07 To: 1994-11-10

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 g powder
- Concentration: neat - moistened with water

VEHICLE
- Amount(s) applied: sufficient double distilled water 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: ca. 6 cm2
- % coverage: not stated
- Type of wrap if used: surgical gauze and semi-occlusive dressing; wrapped with elastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing: with luke warm water
- Time after start of exposure: 4 h

SCORING SYSTEM: scored according to OECD 404/Draize.

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
other: individual scores for 3 animals
Time point:
other: 24, 48, 72 h mean
Score:
0
Max. score:
8
Reversibility:
other: not applicable
Remarks on result:
other: non-irritant
Irritant / corrosive response data:
No erythema or oedema was seen at any of the observation times of 1, 24, 48 and 72 h. See table 1.
Other effects:
No effect on bodyweight. No other effects reported.

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/eschar

Edema

Max. score: 4

Max. score: 4

1 h

0/0/0

0/0/0

24 h

0/0/0

0/0/0

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

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 non-irritant to the skin of rabbits. The report notes the test material would be classified non-irritant; current EC criteria would concur with this finding.