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EC number: 606-947-1 | CAS number: 221640-21-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from January to February 1996
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- A combined study on acute dermal toxicity and on local tolerance was used to assess skin irritation/corrosion. The study design and reporting deviates from the current OECD TG 404, however, the study is considered sufficient for assessment of this endpoint.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 17 July 1992
- Deviations:
- yes
- Remarks:
- - exposure time 24 hrs instead of 4 hrs, 6 animals instead of 3, few details in test description and reporting
- GLP compliance:
- no
Test material
- Reference substance name:
- (S)-1-(4-Ethoxybenzyl)-3-azapentane-1,5-diaminedihydrochloride
- EC Number:
- 606-947-1
- Cas Number:
- 221640-21-7
- Molecular formula:
- C13 H23 N3 O . 2 Cl H
- IUPAC Name:
- (S)-1-(4-Ethoxybenzyl)-3-azapentane-1,5-diaminedihydrochloride
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Han:WIST (SPF)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Schering AG, Germany
- Mean weight at study initiation: 104-106 g (males) or 98-105 g (females)
- Housing: 1 animal per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 23
- rel. Humidity (%): 50 - 58
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- other: 900 mg NaCl ad 100 mL bidist. water
- Controls:
- other: the untreated skin served as control
- Amount / concentration applied:
- 208-212 mg/male animal or 196-210 mg/female animal
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 14 days
- Number of animals:
- 3 males and 3 females
- Details on study design:
- OBSERVATION TIME POINTS
(indicate if minutes, hours or days) On day 1 at application and after 24 h, 48 h and 72 h.
SCORING SYSTEM: According to Draize et al.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1M; #3M, #4F, #5F, #6F
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal: #2M
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 11 days
- Irritation parameter:
- edema score
- Basis:
- animal: #1- #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
Any other information on results incl. tables
2 out of 4 animals showed local irritations as folIows: animal no. 4F showed a very slight reddening (immediately after removal of the bandage and the substance), patchy on day 2, and animal no. 2M showed reddening, patehy (day 2 and 3), hardening of the skin, patehy (day 4) and skin neerosis (initial stage), spotty (day 5 to 10). All animals were without local findings trom day 11 onwards.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- A combined study on acute dermal toxicity and on local tolerance was conducted . The study design and reporting deviates from the current OECD TG 404, however, the study was considered sufficient for assessment of skin irritation/corrosion.A single dermal administration of the test substance for 24 hours to male and female rats at a dose of 2000 mg/kg was tolerated without any local irritations in 4/6 animals. Following grading at 24, 48 and 72 hours after patch removal 1/6 animals shows a mean value of 2 for erythema/eschar. All animals were without local findings trom day 11 onwards.
- Executive summary:
In a primary dermal irritation study similar to OECD TG 404, young adult Wistar rats, female and male (3/sex) were dermally exposed to 208-212 mg/male animal or 196-210 mg/female animal of Triamine Dihydrochloride in physiological saline for 24 hours. Animals then were observed for 14 days. Irritation was scored by the method according to Draize et al..
Only in one male animal local irritations were observed at 24, 48, and 72 h. These irritations were reversible within 11 days. In this study, the test item is not a dermal irritant.
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