Humic acids, sodium salts

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from August 21, 2007 to September 10, 2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

short term temperature change

Principles of method if other than guideline:

Increasing of temperature of animals room (up to 26.1°C). The limit (in EU Method B.4) for temperature is 20 ± 3°C. The deviation from the limit was short-term and did not influence the wellness of animals and the study results.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Humic acids, sodium salts

EC Number:

268-608-0

EC Name:

Humic acids, sodium salts

Cas Number:

68131-04-4

Molecular formula:

NA

IUPAC Name:

Humic acids, sodium salts

Details on test material:

- Name of test material (as cited in study report): Humic acids, sodium salts
- Molecular formula: not known - UVCB substance
- Molecular weight: not known - UVCB substance
- Substance type: technical product
- Physical state: solid
- Lot/batch No.: 9. 5. 2007/R
- Expiration date of the lot/batch: 05/2022
- Stability under test conditions: stable
- Storage condition of test material: dry conditions

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: breeding farm BioTest s.r.o., Konárovice, 281 25, Czech Republic
- Weight at study initiation: 3.9-4.2 kg
- Housing: individually in cages without bedding in conventional animal room
- Diet (e.g. ad libitum): pelleted standard diet TM-MAK 1 for rabbits and guinea-pigs ad libitum
- Water (e.g. ad libitum): drinking tap water ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): room temperature 17 - 23ºC, permanently monitored
- Humidity (%): 30 – 70 %, permanently monitored
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: close clipping of the fur on the dorsal area

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g (moistened with the smallest amount of water)

Duration of treatment / exposure:

3 min, 1 hour, 4 hours (one animal)
4 hours (2 animals)

Observation period:

1, 24, 48 and 72 hours after exposure

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: fur from area 6x6 cm was removed
- Type of wrap if used: gauze patch, foil and cellulose cotton and held in place with non-irritating tape

REMOVAL OF TEST SUBSTANCE
- Washing: by water
- Time after start of exposure:
1st patch - 3 minutes
2nd patch - 1 hour
3rd patch - 4 hours

SCORING SYSTEM: Exposed rabbit was examined for signs of erythema and oedema at 1, 24, 48 and 72 hours after patch removal.
Scoring system - see Table 1

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 1, 24, 48, 72 hours

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 1, 24, 48, 72 hours

Score:

0

Max. score:

4

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 1, 24, 48, 72 hours

Score:

0

Max. score:

4

Results 4

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 1, 24, 48, 72 hours

Score:

0

Max. score:

4

Results 5

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 1, 24, 48, 72 hours

Score:

0

Max. score:

4

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: 1, 24, 48, 72 hours

Score:

0

Max. score:

4

Irritant / corrosive response data:

No evidence of a irritation/corrosion on the skin.

Other effects:

No symptoms systemic toxicity.
No mortality.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

No skin irritation was caused by 4-hour exposure.

Executive summary:

The test substance was tested in the study for acute dermal irritation/corrosion. Rabbits (New Zealand Albino breed) were used for the test.

Test was performed according to Method B.4 - Acute Toxicity: Dermal Irritation/Corrosion, Directive 2004/73/EC, published in O.J. L 152, 2004.

Three rabbits were exposed to of test substance, applied onto clipped skin for 4 hours using a semi-occlusive dressing.

Skin reactions were evaluated after patch removal and observations were made 1, 24, 48 and 72 hours after exposure.

No other signs of intoxication were observed.