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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:
key study
Study period:
04.01.1995 and 07.01.1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

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)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd.
- Age at study initiation: 12-16 weeks old
- Weight at study initiation: 2.39-2.67 kg
- Housing: Individually in suspended metal cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Five days minimum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-19 oC
- Humidity (%): 49%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: 04.01.1995 and 07.01.1995

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: aqueous solution, administered 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: No data
- Type of wrap if used: patch held in place with a strip of surgical tape, then wrapped in elasticated corset.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test substance was gently swabbed with cotton wool soaked in distilled water.
- Time after start of exposure:

SCORING SYSTEM: Draize.

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
0
Max. score:
8
Irritant / corrosive response data:
There were no signs of skin irritation (only minimal erythema after one hour) in any of the animals.
Other effects:
None

Any other information on results incl. tables

ERYTHEMA AND ESCHAR FORMATION
1 hour   1,1,1
24, 48, 72 hours   0,0,0

OEDEMA FORMATION
No scored responses in any animal

Group total = 0, PDII = 0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In a skin irritation study conducted to OECD 404 and to GLP (reliability score 1), tetrasodium HEDP was not irritating to the skin of rabbits at a concentration of 30%.