Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Endpoint summary
Administrative data
Description of key information
The test substance was applied on the skin of 3 rabbits. No signs of irritation were observed during the 7 day observation period (PSL, 2001).
The test substance was shown to be irritant to the eyes when applied in the eyes of 3 rabbits. The effects were reversible after 7 days (PSL, 2001)
Studies with formulations of the analogue DNNSA showed that this substance is not irritating to the skin and ia severe eye irritant.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- existing study
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Apri1 9 -16, 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study similar to the OECD guideline under GLP
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Millbrook Breeding Labs, Amherst. MA
- Age at study initiation: young adult
- Weight at study initiation: not indicated
- Housing: individually
- Diet: Pelleted Purina Rabbit Chow #5326, ad libitum
- Water: Filtered tap water ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23°C
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48 and 72 hours and 7 days after patch removal
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: 4-p1y gauze pad wrapped with 3 inch Micropore tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:
SCORING SYSTEM:
TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: 4-p1y gauze pad wrapped with 3 inch Micropore tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): removal of residual test substance with mineral oil, acetone and water
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- ca. 1.6
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- ca. 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- not irritant, no signs of corrosion
- Other effects:
- no signs of gross toxicity, adverse pharmacologic effects or abnormal behavior
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance is not irritating to the skin.
- Executive summary:
The test substance was applied on the skin of 3 rabbits. No signs of irritation were observed during the 7 day observation period. According to the CLP criteria the test substance is not considered to be irritant to the skin.
Reference
Animal no |
1 |
2 |
3 |
||||||||||||
Day |
1 |
24 |
48 |
72 |
7 |
1 |
24 |
48 |
72 |
7 |
1 |
24 |
48 |
72 |
7 |
erythema |
2 |
2 |
1 |
1 |
0 |
2 |
2 |
2 |
1 |
0 |
2 |
2 |
2 |
2 |
0 |
oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
1 |
1 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The key study is similar to a guideline study and performed under GLP
Justification for selection of eye irritation endpoint:
Key study according to the guideline and performed under GLP
Effects on eye irritation: irritating
Justification for classification or non-classification
Based on the study results the substance is considered non-irritant to the skin, but irritating to the eyes. According to CLP (Regulation EC No 1272/2008) the substance needs to be classified H319 (category 2: Causes serious eye irritation)
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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