Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
March 24, 1986-May 12, 1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
Benzenesulfonic acid, C10-13-alkyl derivs., sodium salts
EC Number:
270-115-0
EC Name:
Benzenesulfonic acid, C10-13-alkyl derivs., sodium salts
Cas Number:
68411-30-3
Molecular formula:
Not applicable for UVCB
IUPAC Name:
sodium 4-undecylbenzenesulfonate
Details on test material:
Alkylbenzene sulfonate, sodium salt (designated as P-500 N-Na). Activity 47%. Average alkyl chain length = C11.2. Clear yellow liquid, stored at ambient temperature.

Test animals / tissue source

Species:
rabbit
Strain:
other: New Zealand albino
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Froxfield Rabbits and Buckmasters
- Age at study initiation: 9-13 weeks
- Weight at study initiation: 2.1-3.1 kg
- Housing: individually housed in metal cages, identified by aluminum ear tags
- Diet (e.g. ad libitum): SDS Standard Rabbit Diet, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation: yes


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 degree C
- Humidity (%): 30-70
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light): 12 hrs light/12 hrs dark


IN-LIFE DATES: From: March 24, 1986 To: May 12, 1986

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.1 mL aliquot of P-500 N-Na
Duration of treatment / exposure:
For three rabbits the eyelids were then gently held together for one second before releasing.
For three other rabbits the eyes were irrigated with water for 5 minutes following a 4-second exposure.
For the remaining three rabbits the eyes were irrigated for 5 minutes following a 30-second exposure.
Observation period (in vivo):
Eyes were examined after 1 hour and 1, 2, 3, 4, 7, 14 and 21 days after exposure.
Number of animals or in vitro replicates:
9
Details on study design:

SCORING SYSTEM: Draize scale

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24, 48, and 72 hrs
Score:
1.75
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: not rinsed
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24, 48, and 72 hrs
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: rinse after 4 seconds
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24, 48, and 72 hrs
Score:
1.06
Max. score:
2
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: rinsed after 30 seconds
Irritant / corrosive response data:
The following results were noted:
1) Three animals without any rinsing:  averaged irritation scores (24, 48, 72 hours) for each animal: cornea 2.3, 1.7, 2; iris: 1.3, 0, 0; conjunctivae redness: 3, 1.7, 2; conjunctivae chemosis: 3, 2, 2.  In the first animal the effects were persistent at day 21.
2) Three animals with rinsing for five minutes following a 30 second exposure: averaged scores: cornea 0.7, 1, 1.3; iris: 0, 0.7, 0.3; conjunctivae redness: 1.7, 2, 1.3; conjunctivae chemosis: 2, 1.3, 2.  The eyes were normal 7 or 14 days after instillation.
3) Three animals with rinsing for five minutes following a 4 second exposure: averaged scores: cornea 0.7, 2.3, 0.7; iris: 0, 0, 0; conjunctivae redness: 1.7, 1.7, 1; conjunctivae chemosis: 1.3, 2, 1.  The eyes were normal 7 days after instillation.

Findings lead to a definition of irritating for LAS at 47% applied without rinsing, irritating (even if with lower effects, mainly as cornea opacity and conjunctivae redness) with rinsing after 30 second of exposure, and not irritating with rinsing after 4 second of exposure.

Any other information on results incl. tables

Results of Eye Irritation Study ¿ No Rinsing

Hours

Days

Animal

1

24

48

72

4

7

14

21

1

Cornea

2

1

2

4

3B

3B

3BC

3BC

Iris

0

1

1

2

1

1

1

0

Conjunctiva - Erythema

1

3

3

3

3

3

2

1

Conjunctiva ¿ Chemosis

2

3

3

3

3

2

2

1

2

Cornea

1

1

2

2

2

1

0

Iris

0

0

0

0

0

0

0

Conjunctiva - Erythema

1

1

2

2

1

0

0

Conjunctiva ¿ Chemosis

1

2

2

2

1

0

0

3

Cornea

1

2

2

2

2

1

0

Iris

0

0

0

0

1

0

0

Conjunctiva - Erythema

1

2

2

2

2

1

0

Conjunctiva ¿ Chemosis

1

2

2

2

2

0

0

Results of Eye Irritation Study ¿ Rinsing after 4 Seconds

Hours

Days

Animal

1

24

48

72

4

7

1

Cornea

0

0

1

1

1

0

Iris

0

0

0

0

1

0

Conjunctiva - Erythema

1

2

2

1

2

0

Conjunctiva ¿ Chemosis

2

2

1

1

1

0

2

Cornea

0

2

3

2

0

0

Iris

0

0

0

0

0

0

Conjunctiva - Erythema

1

2

2

1

2

0

Conjunctiva ¿ Chemosis

2

2

2

1

1

0

3

Cornea

0

1

0

1

1

0

Iris

0

0

0

0

0

0

Conjunctiva - Erythema

1

1

1

1

2

0

Conjunctiva ¿ Chemosis

2

1

1

1

1

0
Results of Eye Irritation Study ¿ Rinsing after 30 Seconds

Hours

Days

Animal

1

24

48

72

4

7

14

1

Cornea

0

1

0

D

D

1

0

Iris

0

0

0

0

0

0

0

Conjunctiva - Erythema

1

2

2

1

1

1

0

Conjunctiva ¿ Chemosis

2

1

1

0

0

0

0

2

Cornea

0

1

1

1

2

0

Iris

0

0

1

1

0

0

Conjunctiva - Erythema

1

2

2

2

2

0

Conjunctiva ¿ Chemosis

2

1

2

1

1

0

3

Cornea

0

1

2

1

2A

2AB

0

Iris

0

0

0

1

1

1

0

Conjunctiva - Erythema

1

1

1

2

2

2

0

Conjunctiva ¿ Chemosis

2

2

2

2

1

1

0

A ¿ Loss of Corneal Epithelium

B ¿ Vascularization

C ¿ Pannus

D ¿ Dulling of the Cornea

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
When not rinsed, damage to the eyes due to the test substance was not reversed within 21 days. According to EU GHS guidelines the test substance is a category 1 eye irritant.
Executive summary:

This study examined the potential of the test substance to cause irritation to eyes. Groups of three rabbits had 0.1 ml of test substance placed in each of their eyes. In one group, the eyes were not rinsed. In the second group, the eyes were rinsed after 4 seconds of exposure. In the third group, the eyes were rinsed after 30 seconds of exposure. Observations were made one hour and 1, 2, 3, 4, 7, 14, and 21 days after exposure. Severe irritation was noted in the animals whose eyes were not rinsed. This irritation was not resolved in one of these animals at the end of 21 days. Irritation was also seen in the animals rinsed after 30 seconds, although the irritation was not as severe, and the effects were fully reversible within 14 days. Mild irritation was seen in the animals rinsed after 4 seconds. These effects were fully reversible within 7 days. Since OECD guideline 405 for eye irritation studies calls for an exposure of at least 24 hrs, the results for unrinsed eyes were used for classification. According to these results, the test substance is a category 1 eye irritant because it caused damage that was not reversible within 21 days.