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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
06 Oct - 03 Nov 2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report date:
2015

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit

Test material

Constituent 1
Chemical structure
Reference substance name:
Bis(triethoxysilylpropyl)amine
EC Number:
236-818-1
EC Name:
Bis(triethoxysilylpropyl)amine
Cas Number:
13497-18-2
Molecular formula:
C18H43NO6Si2
IUPAC Name:
bis(triethoxysilylpropyl)amine

Test animals / tissue source

Species:
rabbit
Strain:
other: New Zealand White Rabbits Crl:KBL (NZW)
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, 97633 Sulzfeld, Germany
- Age at study initiation: approximately 26 - 28 weeks old
- Weight at study initiation: > 2 kg
- Housing: ABS-plastic rabbit cages, floor 4200 cm²
- Diet: autoclaved hay and to Altromin 2123 maintenance diet for rabbits (lot no. 0724) ad libitum rich in crude fibre
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3 °C
- Humidity (%): 55 ± 10%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated contralateral eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
single application without rinsing
Observation period (in vivo):
13 days
Reading time points: 1, 24, 48, and 72 h and daily up to 13 days post-application
Number of animals or in vitro replicates:
2 females
Details on study design:
SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 11 d
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 10 d
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.67
Max. score:
2
Reversibility:
fully reversible within: 6 d
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 9 d
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 13 d
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 13 d
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.33
Max. score:
4
Reversibility:
fully reversible within: 13 d
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2.33
Max. score:
4
Reversibility:
fully reversible within: 10 d
Irritant / corrosive response data:
One hour post exposure, effects on iris (grade 1, 2/2 animals), conjunctivae redness (grade 1 and 2, 2/2 animals) and chemosis (grade 3, 2/2 animals), were observed. In addition, discharge (grade 2) was observed in both animals at 1 h and was fully reversible within 13 days. Mean values over 24, 48, and 72 h for cornea were 0.67 and 1, respectively. After 48 h in both animals corneal opacity was 100% and the irises were red and discoloured. After 72 h cornea opacity was 50% in animal 1 and 2. Mean scores over 24, 48, and 72 h for iris were 0.67 and 1 respectively. Conjuntivae redness mean scores were 2 and 3, respectively. Chemosis mean score was 2.33 in both animals. Any effect observed was fully reversed at the end of the observation period.
Other effects:
The body weight development of both animals during the observation period was within the expected range.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria are met, Category 2 (irritating to eyes) classification required according to Regulations (EC) No 1272/2008
Conclusions:
CLP: eye irrit. Cat. 2 (H319)

Under the conditions of the present study, a single ocular application of the test item Bis(triethoxysilylpropyl)amine to rabbits at a dose of 0.1 mL produced irritant effects, which were fully reversible within 13 days. Neither mortalities nor significant clinical signs of toxicity were observed.