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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study with GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
1-Octadecanol, phosphate, potassium salt
EC Number:
273-489-3
EC Name:
1-Octadecanol, phosphate, potassium salt
Cas Number:
68987-29-1
Molecular formula:
not applicable for UVCB substances
IUPAC Name:
Reaction product of Phosphorus Pentoxide and 1-Octadecanol, neutralized with potassium hydroxide
Test material form:
other: emulsion
Details on test material:
Name of test material (as cited in study report): Silastol H 200
- CAS No.: 68987-29-1

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River, Deutschland GmbH, Stolzenseeweg 32-36, 88353 Kil1legg
- Weight at study initiation: 2.9 - 3.1 kg
- Housing: individually in PPO cages (floor area: 2576 sq.cm) with perforated floor.
- Diet (e.g. ad libitum): Altromin 2123 from Altromin, 0-32791 Lage, Lippe, ad libitum
- Water (e.g. ad libitum): domestic quality drinking water acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 3°C
- Humidity (%): 55% ± 15%
- Air changes (per hr): 10 times/hour
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours darkness

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye served as control
Amount / concentration applied:
0.1 ml of the undiluted test article
Duration of treatment / exposure:
no washing
Observation period (in vivo):
7 days
The eyes were examined and the grade of ocular reaction was recorded one hour and 24 hours later.
The eyes were also examined 48 and 72 hours as well as 7 days after the treatment.
Number of animals or in vitro replicates:
3 animals
Details on study design:
REMOVAL OF TEST SUBSTANCE: no

SCORING SYSTEM: according to OECD guideline 405

TOOL USED TO ASSESS SCORE: fluorescein after 24 hours, UV-light was used to detect possible corneal damage.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: mean 24, 48 and 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: mean 24, 48 and 72 hours
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: mean 24, 48 and 72 hours
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
iris score
Basis:
animal: 1,2,3
Time point:
other: mean 24, 48 and 72 hours
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean 24, 48 and 72 hours
Score:
2.67
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal: 2,3
Time point:
other: mean 24, 48 and 72 hours
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean 24, 48 and 72 hours
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal: 2, 3
Time point:
other: mean 24, 48 and 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritant / corrosive response data:
Very well-defined signs of irritation were observed on the treated eyes.
All effects were fully reversible within 7 days.
Individual data are presented in the table below.

Applicant's summary and conclusion

Interpretation of results:
Category 2A (irritating to eyes)
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP; EU GHS (Regulation (EC) No 1272/2008)
Conclusions:
Classification is based on individual mean scores of 24, 48 and 72 hour scorings, considering reversibility.
Executive summary:

The local effect of SILASTOL H 200 was investigated according to the method recommended in the OECD Guideline No. 405, "Acute Eye Irritationl Corrosion", Feb. 1987, and EEC Guideline 8.5 "Acute Toxicity (Eye Irritation)", Jan. 1997.

Three female albino rabbits were exposed to 0.1 ml of the test article in one eye. The eyes were examined and the changes were graded according to a numerical scale one hour, 24, 48 and 72 hours as well as 7 days after dosing.

Very well-defined signs of irritation were observed on the treated eyes. All effects were fully reversible within 7 days.

Based on the respective mean conjunctivae scores of 2.67, 2 and 2 classification in category 2 is required according to CLP; EU GHS (Regulation (EC) No 1272/2008).