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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
29.4-2.5.2002
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Humic acids and fulvic acids extracted from leonardite, reaction product with formaldehyde, potassium hydrogen sulfite, sodium hydrogen sulfite and potassium hydroxide
Molecular formula:
NA, macromolecular compound
IUPAC Name:
Humic acids and fulvic acids extracted from leonardite, reaction product with formaldehyde, potassium hydrogen sulfite, sodium hydrogen sulfite and potassium hydroxide
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Humic acids, sulfonated
- Lot/batch No.: #05J-9

Test animals / tissue source

Species:
rabbit
Strain:
other: New Zealand albino
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Received from Davidson's Mill Farm, South Brunswick, NJ
- Age at study initiation: Yound adult
- Housing: the animals were singly housed in suspended stainless steel caging. Litter paper was placed beneath the cage and was changed at least three times/week.
- Diet (e.g. ad libitum): Pelleted Purina Rabbit Chow #5326
- Water (e.g. ad libitum): Filtered tap water was supplied ad libitum by automatic water dispensing system.
- Acclimation period: 10 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.05-0.06g
Duration of treatment / exposure:
1 instillation at Day 1.
Observation period (in vivo):
Ocular irritation was evaluatet at 1, 24, 48 and 72 hours post-instillation.
Number of animals or in vitro replicates:
3 females
Details on study design:
SCORING SYSTEM:
The time interval with the highest measn score (Maximum Mean Total Score - MMTS) for all rabbits was used to classify the test substance by the system of Kay and Calandra (J.Sos.Cos.Chem 1962; 13:281-289)


TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein
Ocular irritation was evaluated using a high-intensity which light (Mag Lite) in accordance with Draize et al. (J.Pharmacol.Exp.Ther. 1944;82:377-390)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 48 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 72 h
Score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 h
Score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 48 h
Score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 72 h
Score:
0
Irritant / corrosive response data:
All animals appeared active and healthy. Apart from conjunctivae redness in one animal after 24 h, there were no other signs of gross toxicity, adverse pharmacologic effect or abnormal behavior. No corneal opacity or irititis was observed in any treated eye during the study.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
The substance was tested for primary eye irriation according to OPPTS 870.2400, and does not meet the criteria for classification as Irritant according to Regulation (EC) No 1272/2008 (CLP).