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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Skin irritation
Six rabbits were exposed to the test substance dermally for 24 hours under occlusion (PSL 1981 (1), PSL 1981 (2)). The test substance initiated irritation of the skin at 24 and 72 h observations. This irritation was not shown to be reversible. Therefore the test substance is classified as skin irritant category 2.
Eye irritation
Six rabbits were treated with the test substance in an eye irritation test (PSL 1981 (1), PSL 1981 (2)). During the observation period of 72 hours severe eye irritation was reported (including effects on cornea), which was not shown to be reversible within 72 hours. In view of the absence of effects on the iris and a mean maximum overall score of 1.3 for cornea, it was concluded that the test substance is a category 2 eye irritant.
Studies on skin and eye irritation toxicity are available on DNNSA and BaDNNSA. These studies are indicative of moderate to severe irritation and therefore show that both DNNSA and BaDNNSA are suitable candidates for read-across.

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
Study period:
january 1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: limited report, non-GLP, results are indicative for irritation and represent a worst case (24 h exposure under occlusion). The information in the report is limited to the information in the summary.
Qualifier:
according to guideline
Guideline:
other: FHSLA 16 CFR 1500
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Cedar Knoll
- Age at study initiation: not indicated
- Weight at study initiation: no data
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22 °C
- Humidity (%): not indicated
- Air changes (per hr): not indicated
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
occlusive
Preparation of test site:
other: clipped and abraded
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 mL
- Concentration (if solution): 50% in diluent oil

Duration of treatment / exposure:
24 hours
Observation period:
scored at 24 and 72 hours
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm2 (two times, one for clipped skin, other for abraded skin)
- Type of wrap if used: occlusive, rubberized elastic cloth

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hours

SCORING SYSTEM: Draize
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 h
Score:
4
Remarks on result:
other: non-abraded skin
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 h
Score:
3.86
Reversibility:
not reversible
Remarks on result:
other: non-abraded skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24
Score:
3
Remarks on result:
other: non-abraded skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 h
Score:
0.83
Reversibility:
not reversible
Remarks on result:
other: non-abraded skin
Irritant / corrosive response data:
irritant
Other effects:
none reported
Interpretation of results:
Category 2 (irritant)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance is irritating to the skin
Executive summary:

Six rabbits were exposed to the test substance dermally for 24 hours under occlusion. The test substance initiated irritation of the skin at 24 and 72 h observations. This irritation was not shown to be reversible. Therefore the test substance is classified as skin irritant category 2.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
january 1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: limited report, non GLP, effects were not shown to be reversible, The information in the report is limited to the information in the summary.
Qualifier:
according to guideline
Guideline:
other: FHSLA 16 CFR 1500
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Cedar Knoll
- Age at study initiation: young adult
- Weight at study initiation: not reported
- Housing: individually
- Diet: Fisher Rabbit Pellets ad libitum
- Water: ad libitum
- Acclimation period: 18 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22 °C
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 mL
- Concentration (if solution): 50%

Observation period (in vivo):
scored 24, 48 and 72 hours after application
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): none

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: not indicated
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24-72 h
Score:
ca. 1.3
Max. score:
2
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24-72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: 24-72 h
Score:
ca. 2.7
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Remarks:
discharge
Basis:
mean
Time point:
other: 24-72 h
Score:
ca. 1.6
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24-72 h
Score:
ca. 2.6
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Irritant / corrosive response data:
irritant
Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance induced eye irritation
Executive summary:

Six rabbits were treated with the test substance in an eye irritation test. During the observation period of 72 hours severe eye irritation was reported, which was not shown to be reversible. In view of the absence of effects on the iris and a mean overall score of 1.3 for cornea, it was concluded that the test substance is a category 2 eye irritant.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The available studies contain sufficient information to be used for classification and labelling.


Justification for selection of skin irritation / corrosion endpoint:
Studies were conducted prior to GLP regulations but used methods generally consistent with accepted procedures. Two studies of equal quality are available. Both can be indicated as key-study. The results of both studies are comparable.

Justification for selection of eye irritation endpoint:
Studies were conducted prior to GLP regulations but used methods generally consistent with accepted procedures. Two studies of equal quality are available. Both can be indicated as key-study. The results of both studies are comparable

Effects on skin irritation/corrosion: irritating

Effects on eye irritation: moderately irritating

Justification for classification or non-classification

Based on the outcome of the available tests, the test substance needs to classified as skin irritant (CLP category 2, H315: Causes skin

irritation) and severe eye irritant (CLP category 2, H319: Causes serious eye irritation).