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Toxicological information

Skin irritation / corrosion

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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 a read accross from sodium 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:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals 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:
The result is a read accross from sodium citrate (CAS 68-04-2) from a reliable study conducted in accordance with OECD 404 and GLP. The test material was found 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.