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Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 07 July 2010 to ...........
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Compliant to GLP and testing guideline; adequate coherence between data, comments and conclusions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
Reaction mass of sodium sulfate, sodium amino-12-dodecanoate and sodium dodecanoediate
IUPAC Name:
Reaction mass of sodium sulfate, sodium amino-12-dodecanoate and sodium dodecanoediate
Details on test material:
- Name of test material (as cited in study report): Reaction mass of sodium sulfate, sodium amino-12-dodecanoate and sodium dodecanoediate
- Substance type: UVCB
- Physical state: brown liquid
- Purity test date: 26 march 2009
- Lot/batch No.: T710/712
- Expiration date of the lot/batch: 20 September 2010
- Storage conditions of test material: at room temperature.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Breeder: Grimaud Frères Sélection S.A.S., La Corbière, Roussay, France
- Age at study initiation: 2 to 4 months
- Weight at study initiation: mean body weight ± standard deviation of 2.7 ± 0.2 kg
- Housing: Pajon cages
- Diet (e.g. ad libitum): 112C pelleted diet
- Water (e.g. ad libitum): drinking water filtered by a FG Millipore membrane
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3°C
- Humidity (%): 50 ± 20%
- Air changes (per hr): 12 cycles/hour
- Photoperiod (hrs dark / hrs light): 12 h / 12 h

IN-LIFE DATES: From 20 July 2010 to 31 August 2010

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: For each rabbit, the right eye, which remained untreated, served as control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL.
Duration of treatment / exposure:
Single application to the eye.
Observation period (in vivo):
22 days
Number of animals or in vitro replicates:
Three males.
Details on study design:
SCORING SYSTEM: Draize scale.

TOOL USED TO ASSESS SCORE: UV lamp and 0 5% of sodium fluorescein solution.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
(Chemosis)
Basis:
mean
Remarks:
3 rabbits
Time point:
other: 24, 48 and 72 h
Score:
2.76
Max. score:
3
Reversibility:
fully reversible within: 21 days
Remarks on result:
other: Individual score = 2.3 + 3 + 3
Irritation parameter:
conjunctivae score
Remarks:
(discharge)
Basis:
mean
Remarks:
3 rabbits
Time point:
other: 24, 48 and 72 hours
Score:
1.33
Max. score:
3
Reversibility:
fully reversible within: 21 days
Remarks on result:
other: Individual scores = 1 + 1.7 + 1.3
Irritation parameter:
cornea opacity score
Remarks:
(opacity)
Basis:
mean
Remarks:
3 rabbits
Time point:
other: 24, 48 and 72 hours
Score:
2.77
Max. score:
4
Reversibility:
fully reversible within: 21 days
Remarks on result:
other: Individual scores = 3 + 2.3 + 3
Irritation parameter:
cornea opacity score
Remarks:
(area)
Basis:
mean
Remarks:
3 rabbits
Time point:
other: 24, 48 and 72 hours
Score:
3.04
Max. score:
4
Reversibility:
fully reversible within: 21 days
Remarks on result:
other: Individual scores = 2.7 + 3.7 + 2.7
Irritant / corrosive response data:
First animal (No. 524)
From day 1 until day 13, very slight toa moderate or marked conjunctival reactions (very slight to moderate chemosis (grade 2 or 3) was noted and
the evaluation of redness of the conjunctiva was masked by a black discoloration of the eye. Then, slight chemosis and redness of the conjunctiva
(grade 1) were observed from day 14 until day 20.
A clear discharge was noted on days 2 and 3.
Evaluation of iris lesions was masked by a black discoloration of the eye from day 1 until day 4. Then, iris lesions (grade 1) were noted until day 8.
Evaluation of corneal opacity was masked by a black discoloration on day 1. Then, a slight to severe corneal opacity (grades 1 to 3), which covered the whole cornea between day 5 and day 8) was noted from day 2 until day 12.
A brownish substance was noted from day 2 until day 22, associated with neovascularisation on day 22., very slight or slight redness of the
conjunctiva and clear to whitish purulent discharge) were observed in all animals from day 1: some of these reactions persisted up to day 10 at the
latest.
A slight iritis was noted in all animals on day 2; it persisted up to day 8, 9 or 10.
A slight corneal opacity was recorded in all animals on day 2; it persisted up to day 9 or 17.
Neovascularisation was noted in all animals, from day 3 or day 5 up to day 8, 10 or 12.

Second animal (No. 514)
A moderate or marked chemosis (grade 2 or 3) was noted from day 1 until day 9. Then, a slight chemosis (grade 1) was noted until day 13.
Evaluation of redness of the conjunctiva was masked by a black discoloration of the eye on days 1 and 2. Then, a slight or moderate redness of the
conjunctiva (grade 1 or 2) was noted until day 6
A clear discharge was noted from day 2 until day 4.
Evaluation of iris lesions and corneal opacity were masked by a black discoloration of the eye on day 1. Then, iris lesions (grade 1) were noted until
day 6 and a slight to severe corneal opacity (grades 1 to 3), which covered the whole cornea Evaluation of iris lesions and corneal opacity were
masked by a black discoloration of the eye on day 1. Then, iris lesions (grade 1) were noted until day 6 and a slight to severe corneal opacity
(grades 1 to 3), which covered the whole cornea on days 2 and 3) was noted from day 2 until day 8.
A brownish substance was noted from day 2 until day 6, followed by a neovascularisation on days 8 and 9.

Third animal (No. 522)
A moderate or marked chemosis was noted from day 1 until day 8. Then, a slight chemosis (grade 1) was noted until day 22.
Evaluation of redness of the conjunctiva was masked by a black discoloration of the eye on day 1. A moderate or severe redness of the conjunctiva
(grade 2 or 3) was noted from day 2 until day 6. Then, a slight redness of the conjunctiva (grade 1) was noted until day 12.
A clear discharge was noted on days 2 and 3.
Evaluation of iris lesions was masked by a black discoloration of the eye on day 1. Then, iris lesions (grade 1) were noted until day 5.
Evaluation of corneal opacity was masked by a black discoloration on day 1. Then, a slight to severe corneal opacity (grades 1 to 3) was noted from
day 2 until day 7.
A neovascularisation was noted from day 3 until day 6 and a brownish substance was noted from day 4 until day 22.

Mean scores calculated over 24, 48 and 72 hours were:
- for chemosis: 2.3, 3.0 and 3.0 for animals Nos.524, 514 and 522, respectively,
- for corneal opacity: 3.0, 2.3 and 3.0 for each animal Nos.524, 514 and 522, respectively,
- for redness of the conjunctiva: 3.0 for animal No. 522,
- for the iris lesions: 1.0 for animals Nos. 514 and 522.
Due to eye discoloration, the mean scores were not calculable in the animals Nos. 524 and 514 for redness of the conjunctiva and in the animal No. 524 for the iris lesions.

Any other information on results incl. tables

Table : Individual ocular examinations and mean values f the scores recorded for each animal (24, 48/ and 72 hours).

 

Rabbit number

Region of eye

Description of ocular reactions

Scores

Mean score irritation2

Fully reversible

1h

D1

24h

D2

48h

D3

72h

D4

524

Conj1

Chemosis

3

3

2

2

2.3

Yes (D21)

Redness

LC

LC

LC

LC

-

Yes (D21)

Discharge

E

2

1

0

1.0

Yes (D4)

Iris

LC

LC

LC

LC

-

Yes (D9)

Cornea

Intensity

LC

3

3

3

3.0

Yes (D13)

Area

LC

2

3

3

2.7

Yes (D13)

514

Conj1

Chemosis

3

3

3

3

3.0

Yes (D14)

Redness

LC

LC

2

2

-

Yes (D7)

Discharge

E

3

1

1

1.7

Yes (D5)

Iris

LC

1

1

1

1.0

Yes (D7)

Cornea

Intensity

LC

3

2

2

2.3

Yes (D9)

Area

LC

4

4

3

3.7

Yes (D9)

522

Conj1

Chemosis

3

3

3

3

3.0

No at D22

Redness

LC

3

3

3

3.0

Yes (D12)

Discharge

E

2

2

0

1.3

Yes (D4)

Iris

LC

1

1

1

1.0

Yes (D6)

Cornea

Intensity

LC

3

3

3

3.0

Yes (D13)

Area

LC

3

3

2

2.7

Yes (D13)

 

1Conj = Conjunctivae

2Mean score on days 2, 3 and 4

E = Scoring masked by residual test item

LC = reading masked by a lack discoloration of the eye

Applicant's summary and conclusion

Interpretation of results:
highly irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: Regulation EC n°1272/2008
Conclusions:
The test item, Reaction mass of sodium sulfate, sodium amino-12-dodecanoate and sodium dodecanoedioate, (batch No. T710/712) was severely
irritant when administered by ocular route to rabbits.
Executive summary:

The objective of this study was to evaluate the potential of the test item, Reaction mass of sodium sulfate, sodium amino-12-dodecanoate and sodium dodecanoedioate, to induce irritation following a single ocular administration in rabbitsaccording to OECD (No. 405, 24th April 2002) andCommission Regulation (EC) (No. 440/2008, B.5, 30 May 2008)guidelines.

The study was conducted in compliance with the principles of Good Laboratory Practice Regulations.

 

Methods

The test item, Reaction mass of sodium sulfate, sodium amino-12-dodecanoate and sodium dodecanoedioate, was first administered to a single male New Zealand White rabbit.

Since the test item was irritant on this first animal, it was then evaluated in sequential manneron two other animals.

The quantity of the test item administered was 0.1 mL.

For animal Nos. 514 and 522, a local anaesthetic was used prior to treatment.

The test item was introducedinto the conjunctival sac of the left eye. The right eye, which remained untreated, served as control.

The eyes were not rinsed after administration of the test item.

Ocular reactions were observed approximately 1 hour, 24, 48 and 72 hours after the administration and then daily until the reversibility of the ocular reactions (day 14; one animal) or the end of the observation period (two animals).

Body weight was recorded at the beginning and the end of the observation period. On completion of the observation period, the animals were sacrificed then discarded without macroscopicpost‑mortemexamination.

 

The mean values of the scores for chemosis, redness of the conjunctiva, iris lesions and corneal opacity were calculated for each animal.

The interpretation of results was carried out according to the classification criteria laid down in Council Directive 67/548/EEC (and subsequent adaptations).

 

Results

Slight to marked chemosis was noted in all animals from day 1 until day 13, 20 or 22.

Evaluation of redness of the conjunctiva was masked by a black eye discoloration in all animals on day 1 or from day 1 until day 2 or 13. Then slight to severe redness of the conjunctiva was noted until day 6, 12 or 20.

A clear discharge was noted in all animals, from day 2 until 3 or 4.

Evaluation of iris lesion was masked by a black eye discolorationin all animals on day 1 (two animals) or from day 1 until day 4 (one animal). Then, iris lesions were noted until day 5, 6 or 8. The evaluation of corneal opacity was masked by a black eye discoloration on day 1. Then, slight to marked corneal opacity, which covered the whole cornea in two animal during 2 or 4 consecutive days, was noted until day 7, 8 or 12.

Brownish area was noted in all animals from day 2 or 3 until day 6 (one animal) or 22 (two animals). Neovascularisation was observed on days 8 and 9 (one animal) from day 3 until day 6 (one animal) or on day 22 (one animal).

Mean scores calculated over 24, 48 and 72 hours were:

.            for chemosis: 2.3, 3.0 and 3.0 for each animal,

.            for corneal opacity: 3.0, 2.3 and 3.0 for each animal,

.            for redness of the conjunctiva: 3.0 for animal No. 522,

.            for the iris lesions: 1.0 for animals No. 514 and 522.

Due to eye discoloration, the mean scores were not calculable in the animals Nos. 524 and 514 for redness of the conjunctiva and in the animal No. 524 for the iris lesions.

 

Conclusion

The test item, Reaction mass of sodium sulfate, sodium amino-12-dodecanoate and sodium dodecanoedioate, was severely irritant when administered by ocular route to rabbits.