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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1984
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Remarks:
Guideline study

Data source

Reference
Reference Type:
other: secondary source
Title:
Unnamed
Year:
2008

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

1
Chemical structure
Reference substance name:
Sodium dodecyl sulphate
EC Number:
205-788-1
EC Name:
Sodium dodecyl sulphate
Cas Number:
151-21-3
Molecular formula:
C12H26O4S.Na
IUPAC Name:
sodium dodecyl sulfate
Specific details on test material used for the study:
OTHER SPECIFICS: C12 > 98 %

Test animals / tissue source

Species:
rabbit
Strain:
other: Kleinrusse Chbb:HM
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Thomae, Germany
- Weight at study initiation: 2092 - 2478 g
- male animals

Test system

Vehicle:
water
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1mL
- Concentration (if solution): 25 % active substance


Duration of treatment / exposure:
single instillation, not rinsed
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
4
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: 0.5 % aqueous fluorescein (cornea)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1 h
Score:
0.75
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 6 hours
Score:
0.75
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
7 d
Score:
1
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
10 d
Score:
0.75
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
14 d
Score:
0.75
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 17 days
Score:
0.75
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
21 d
Score:
0.75
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
other: area of cornea involved
Basis:
mean
Time point:
other: 1 h
Score:
1.5
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
other: area of cornea involved
Basis:
mean
Time point:
other: 6 h
Score:
1.25
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
other: area of cornea involved
Basis:
mean
Time point:
24 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
other: area of cornea involved
Basis:
mean
Time point:
48 h
Score:
3.25
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
other: area of cornea involved
Basis:
mean
Time point:
72 h
Score:
3.25
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
other: area of cornea involved
Basis:
mean
Time point:
7 d
Score:
2.75
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
other: area of cornea involved
Basis:
mean
Time point:
10 d
Score:
2.25
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
other: area of cornea involved
Basis:
mean
Time point:
14 d
Score:
2.25
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
other: area of cornea involved
Basis:
mean
Time point:
other: 17 d
Score:
2.25
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
other: area of cornea involved
Basis:
mean
Time point:
21 d
Score:
1.75
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: 1 hour
Score:
1
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: 6 hours
Score:
2
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
24 h
Score:
2.25
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
48 h
Score:
2.75
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
72 h
Score:
2.75
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
7 d
Score:
2.25
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
10 d
Score:
1.5
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
14 d
Score:
1.25
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: 17 days
Score:
1.25
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
21 d
Score:
1.25
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1h
Score:
1.25
Max. score:
4
Reversibility:
fully reversible within: 14 d
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 6h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 14 d
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24 h
Score:
1.25
Max. score:
4
Reversibility:
fully reversible within: 14 d
Irritation parameter:
chemosis score
Basis:
mean
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 14 d
Irritation parameter:
chemosis score
Basis:
mean
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 14 d
Irritation parameter:
chemosis score
Basis:
mean
Time point:
7 d
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 14 d
Irritation parameter:
chemosis score
Basis:
mean
Time point:
10 d
Score:
0.25
Max. score:
4
Reversibility:
fully reversible within: 14 d
Irritation parameter:
chemosis score
Basis:
mean
Time point:
14 d
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 17 days
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Time point:
21 d
Score:
0
Max. score:
4
Irritation parameter:
other: conjunctivae discharge
Basis:
mean
Time point:
other: 1 h
Score:
3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
other: conjunctivae discharge
Basis:
mean
Time point:
other: 6h
Score:
3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
other: conjunctivae discharge
Basis:
mean
Time point:
24 h
Score:
3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
other: conjunctivae discharge
Basis:
mean
Time point:
48 h
Score:
3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
other: conjunctivae discharge
Basis:
mean
Time point:
72 h
Score:
3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
other: conjunctivae discharge
Basis:
mean
Time point:
7 d
Score:
1
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
other: conjunctivae discharge
Basis:
mean
Time point:
10 d
Score:
2.25
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
other: conjunctivae discharge
Basis:
mean
Time point:
14 d
Score:
1.75
Max. score:
3
Irritation parameter:
other: conjunctivae discharge
Basis:
mean
Time point:
other: 17 d
Score:
1.75
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
other: conjunctivae discharge
Basis:
mean
Time point:
21 d
Score:
0.75
Max. score:
3
Reversibility:
not reversible
Other effects:
Cornea (0.5 % aqueous fluorescein): mean 100 or 40 after 24 hrs or 21 days p.a.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Sodium dodecyl sulfate was highly corrosive for the eyes in this in vivo test in rabbits.
Executive summary:

The IUCLID dataset of C12-Alkylsulfate (CAS 151-21-3) in the OECD SIDS Initial Assessment Profile on Sodium dodecyl sulfate (SDS) describes the following Klimisch 1 study according to OECD Guideline 405.

0.1 mL of the test material was applied in the eyes of 4 male Kleinrusse Chbb:HM rabbits as a solution in water at a concentration 25% of active substance. The eyes were not rinsed.

Observations were made until 21 days post application. Scoring system of Draize was used.

Based on the description of the lesions and the non-reversibility of the effects over the 21 days observation period it is considered that C12-Alkylsulfate (SDS) is highly corrosive for the eyes.

 

Reference:Henkel KGaA (1987) Texapon L 100, Lanette E, Maranil A Paste 75, Texapon T 42, Texapon N 25, Texapon SB 3, Texapon ASV, Nifancol LBE, Forlanit E und Akypro RLM 100.Pruefung auf primaere Schleimhautirritation am Kaninchenauge (Unpublished Report No. TBD 870553). Henkel KGaA, Duesseldorf, 20 pp