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Diss Factsheets

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions. Conducted with 6 animals according to previous version of guideline adopted in 1987. No English translation available.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
conducted with 6 animals according to previous version of guideline adopted in 1987
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
D-Glucopyranose, oligomers, branched and linear C9-11-alkyl glycosides
EC Number:
500-394-9
EC Name:
D-Glucopyranose, oligomers, branched and linear C9-11-alkyl glycosides
Cas Number:
157707-87-4
Molecular formula:
not applicable, UVCB substance
IUPAC Name:
not applicable, UVCB substance
Details on test material:
- Name of test material (as cited in study report): No data
- Physical state: No data
- Analytical purity: 50% AS
- Lot/batch No.: AM-BS

Test animals / tissue source

Species:
rabbit
Strain:
other: Japanese white rabbit
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Sankyo Labo Service
- Age at study initiation: 14 weeks
- Weight at study initiation: 2.75-3.12kg
- Housing: single
- Diet: RC4, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 2
- Humidity (%): 50 ± 10
- Air changes (per hr): 17
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
other: phosphate buffered saline 1/15M pH 7.2
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 mL
- Concentration: 100% (w/v) (50% AS), 30% (w/v) (15% AS), 3% (w/v) (1.5% AS)
Duration of treatment / exposure:
30 s or single application without washing
Observation period (in vivo):
21 days
reading time points: 1, 3, 6, 24, 48, 72 h and 4, 7, 14 and 21 days
Number of animals or in vitro replicates:
9 animals/concentration (3 animals rinsed, 6 animals not-rinsed)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: yes, 3 animals per concentration (lukewarm water 300 mL)
- Time after start of exposure: 30 s

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: 2% fluorescein sodium solution

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: mean after 24/48/72 h
Score:
1.2
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: 50% AS
Irritation parameter:
iris score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: mean after 24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: 50% AS
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: mean after 24/48/72 h
Score:
1.2
Max. score:
3
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: 50% AS
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: mean after 24/48/72 h
Score:
1.2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: 50% AS
Other effects:
No further local or systemic effects were observed.

Any other information on results incl. tables

Table 1: Result of Alkyl polyglucoside eye irritation test in rabbit

sample: 100% (w/w) (50% AS), 0.1 mL, instillation

group animal
No.		 sex body weight
(kg)		 observation time (h)  day after instillation
1 3 6 1 2 3 4 7 14 21
rinse
group		 1 female 3.10 10 10 10 14 12 6 6 6 0 0
2 female 2.75 10 10 10 12 6 4 2 0 0 0
3 female 2.95 14 14 14 14 6 4 2 0 0 0
mean 11.3 11.3 11.3 13.3 8.0 4.7 3.3 2.0 0.0 0.0
I.A.O.I 13.3
no-rinse
group		 4 female 2.90 14 14 14 12 52 52 48 46 32 30
5 female 3.12 12 12 12 8 28 44 46 46 20 20
6 female 2.79 14 14 12 10 50 48 48 26 0 0
7 female 2.80 14 14 12 8 48 48 28 22 0 0
8 female 2.89 14 14 10 8 28 48 28 2 0 0
9 female 2.91 14 14 12 8 28 46 46 42 62 80
mean 13.7 13.7 12.0 9.0 39.0 47.7 40.7 30.7 19.0 21.7
I.A.O.I 47.7

sample: 30% (w/v) (15% AS), 0.1 mL, instillation

group animal
No.		 sex body weight
(kg)		 observation time (h)   day after instillation
1 3 6 1 2 3 4 7 14 21
rinse
group		 10 female 2.90 10 10 10 8 2 0 0 0 - -
11 female 2.91 10 10 10 12 4 2 0 0 - -
12 female 2.85 10 10 10 12 4 0 0 0 - -
mean 10.0 10.0 10.0 10.7 3.3 0.7 0.0 0.0 - -
I.A.O.I 10.7
no-rinse
group		 13 female 2.99 10 10 10 6 4 24 22 0 0 0
14 female 2.76 10 10 10 10 10 8 6 6 2 0
15 female 2.75 10 10 12 12 6 2 2 0 0 0
16 female 2.95 10 10 10 6 26 24 2 0 0 0
17 female 2.99 10 10 10 10 8 4 4 0 0 0
18 female 2.91 12 12 12 6 4 4 4 0 0 0
mean 10.3 10.3 10.7 8.3 9.7 11.0 6.7 1.0 0.3 0.0
I.A.O.I 11.0

sample: 3% (w/v) (1.5% AS), 0.1 mL, instillation

group animal
No.		 sex body weight
(kg)		 observation time(hr)  day after instillation
1 3 6 1 2 3 4 7 14 21
rinse
group		 19 female 2.95 6 6 6 0 0 0 0 0 - -
20 female 2.84 2 2 2 0 0 0 0 0 - -
21 female 2.77 2 2 2 0 0 0 0 0 - -
mean 3.3 3.3 3.3 0 0 0 0.0 0.0 - -
I.A.O.I 3 .3
no-rinsed
group		 22 female 2.89 4 4 4 0 0 0 0 0 - -
23 female 2.94 4 4 4 0 0 0 0 0 - -
24 female 2.86 4 4 2 0 0 0 0 0 - -
25 female 2.88 0 0 0 0 0 0 0 0 - -
26 female 2.89 4 4 0 0 0 0 0 0 - -
27 female 2.94 4 4 0 0 0 0 0 0 - -
mean 3.3 3.3 1.7 0.0 0.0 0.0 0.0 0.0 - -
I.A.O.I 3.3

body weight: at the final quarantine

Classification according to Kay & Calandra:

sample group I.A.O.I. class
100%(w/w)
(50% a.i.)		 rinse 13.3 Minimally irritating
no-rinse 47.7 Severely irritating
30% (w/v)
(15% a.i.)		 rinse 10.7 Mildly irritating
no-rinse 11.0 Mildly irritating
3% (w/v)
(1.5% a.i.)		 rinse 3.3 Minimally irritating
no-rinse 3.3 Minimally irritating

CONCLUSION:

The undiluted test substance (50% AS) has to be classified as inducing severe damage to the eyes (R41) according to the criteria of EU Directive 67/548/EEC and as inducing irreversible effects on the eye (Eye Dam. 1) according to the criteria of Regulation (EC) No 1272/2008 due to a lack of reversibility of corneal effects.

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information 50% AS Criteria used for interpretation of results: EU
Conclusions:
CLP: Eye Dam. 1, H318
DSD: Xi, R 41