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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Description of key information

Ditolylether disulfonic acid disodium salt, isomer mixture causes no irrtating effects neither on the skin of rabbits nor in the eye of rabbits.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study and GLP
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: female: approx. 23-24 weeks
- Weight at study initiation: > 2 kg
- Housing: individually
- Diet ad libitum
- Water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18
- Humidity (%): 55
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: test substance was only moistened
Controls:
other: The opposite site of the treatment area served as control.
Amount / concentration applied:
0.5 g to each test side, moistened with water to ensure good contact to the skin.
Duration of treatment / exposure:
4 hours
Observation period:
up to 72 hours post treatment
Number of animals:
3
Details on study design:
The test item ws applied first to a gauze patch.
To ensure good skin contact it was moistened with tap water.
The patch was then applied to the skin on a small area (approx 6cm² of the left side of the dorsal area ; the right side served as control).
The patch was fixed with a semi-occlusive dressing for a 4-hour period.
At the end of the exposure operiod the residual test item was removed with tap water.
All animals were observed for 72 hours after the patch removal.
Scoring for oedema and erythema was made according to Draize.
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: up to 72 hours
Score:
ca. 0
Max. score:
4
Reversibility:
other: no signs of erythema were reported
Irritation parameter:
edema score
Basis:
mean
Time point:
other: up to 72 hours
Score:
ca. 0
Max. score:
4
Reversibility:
other: no signs of oedema were reported
Irritant / corrosive response data:
No irritant or corrosive effects were observed on the intact skin of thee female rabbits after a contact time of 4 hours.
Other effects:
Neither mortality nor significant clinical signs of toxicity were observed.
Interpretation of results:
not irritating
Remarks:
Migrated information
Executive summary:

Three New Zealand white rabbits received dermal application of 0.5 g moistened ditolylether disulfonic acid disodium salt, isomer mixture to the shaved dorsal skin (left side) for 4 hours. The right side of the dosal skin served as control (OECD TG 404). The test substance was held in place by a semi-occlusive dressing. After termination of the exposure the residue test substance was removed with tap water. The animals were observed for 72 hours post treatment. Under the conditions of the study ditolylether disulfonic acid disodium salt, isomer mixture caused no irritating or corrosive skin effect. No clinical signs of systemic intoxication are observed.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study and GLP
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: animal 1: 19 weeks, animal 2: 34 weeks, animal 3: 30-31 weeks
- Weight at study initiation: > 2 kg
- Diet ad libitum
- Water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18
- Humidity (%): 55
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
other: The untreated eye of each animal served as control.
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
once
Observation period (in vivo):
up to 6 days
Number of animals or in vitro replicates:
3 females
Details on study design:
The test item was applied at a single dose (100 mg) into the conjunctival sac of one eye of each test animal after pulling the lower lid away from eyeball. The lids were then gently held together for about 1 sec in order to prevent loss of the material. The untreated contralateral eye served as control. The treated eye was not rinsed. The eyes were examined for signs of irritation throughout the observation period. The eye irritation was scored according to Draize.
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: up to 72 hours
Score:
ca. 0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: up to 72 hours
Score:
ca. 0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: up to 72 hours
Score:
>= 0.67 - <= 1
Max. score:
3
Reversibility:
fully reversible within: 6 days
Remarks on result:
other: animal 1: score 1 of max 3 for 72 h; animal 2: score 1 for 48 h: amimal 3: score 1 for 72 h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: up to 72 hours
Score:
ca. 0
Max. score:
4
Irritant / corrosive response data:
The only effects observed: Some blood vessels were hyperaemic (conjunctival injections, score 1 of max 3), which was fully reversible within 6 days.
Other effects:
no effects reported
Interpretation of results:
slightly irritating
Remarks:
Migrated information
Conclusions:
The animals showed slightly irritation effects which were fully reversible within 6 days and which do no lead to classification.
Executive summary:

Ditolylether disulfonic acid disodium salt, isomer mixture was tested for eye irritating property using 3 female New Zealand White rabbits. The test item was applied at a single dose (100 mg, undissolved) into the conjunctival sac of one eye of each test animal after pulling the lower lid away from eyeball. The lids were then gently held together for about 1 sec in order to prevent loss of the material. The untreated contralateral eye served as control. The treated eye was not rinsed. The eyes were examined for signs of irritation throughout the observation period. The eye irritation was scored according to Draize. The animals showed slightly irritation effects (conjunctival injections) most probabely due to mechanical irritation by the undissolbed substance. These effects were fully reversible within 6 days and do no lead to classification.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Skin irritation

Threewhite rabbits received dermal application of 0.5 g moistened ditolylether disulfonic acid disodium salt, isomer mixture to the shaved dorsal skin (left side) for 4 hours, the right side of the dosal skin served as control (OECD TG 404). The test substance was held in place by a semi-occlusive dressing. After termination of the exposure the residue test substance was removed weith tap water. The animals were observed for 72 hours post treatment. Under the conditions of the study ditolylether disulfonic acid disodium salt, isomer mixture caused no irritating or corrosive skin effect.

 

Eye irritation

Ditolylether disulfonic acid disodium salt, isomer mixture was tested for eye irritating property usindg 3 female New Zealand White rabbits(OECD TG 405). The test item was applied at a single dose (100 mg) into the conjunctival sac of one eye of each test animal after pulling the lower lid away from eyeball. The lids were then gently held together for about 1 sec in order to prevent loss of the material. The untreated contralateral eye served as control. The treated eye was not rinsed. The eyes were examined for signs of irritation throughout the observation period. The eye irritation was scored according to Draize. The animals showed slightly irritation effects (conjunctival injections) which were fully reversible within 6 days and which do no lead to classification.

 

Overall conclusion

The two studies which are taken into account, are GLP compliant and are of high quality (Klimisch score = 1). Therefore, there is no reason to believe that the above described results would not be applicable to humans.

 


Justification for selection of skin irritation / corrosion endpoint:
only one in vivo study available

Justification for selection of eye irritation endpoint:
only one in vivo study available

Justification for classification or non-classification

Based on the available data no classification and labelling is required.