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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
26 Jan to 29 Jan 1999
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: OECD guideline study, to GLP, with slight deviations which are not expected to affect the outcome.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
temperature slightly outside of recommended range and an occlusive rather than semi occlusive wrap was used. The use of controls has not been specified and the level of examination conducted for signs of clinical toxicity is unspecified
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
temperature slightly outside of recommended range and an occlusive rather than semi occlusive wrap was used. The use of controls has not been specified and the level of examination conducted for signs of clinical toxicity is unspecified
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
1-(N,N-bis(2-hydroxyethyl)amino)propan-2-ol
EC Number:
229-764-5
EC Name:
1-(N,N-bis(2-hydroxyethyl)amino)propan-2-ol
Cas Number:
6712-98-7
Molecular formula:
C7H17NO3
IUPAC Name:
1-[bis(2-hydroxyethyl)amino]propan-2-ol
Test material form:
other: Clear liquid
Details on test material:
- Name of test material (as cited in study report): Diethanolisopropanolamine (DEIPA)
- Substance type: Technical product
- Physical state: Liquid
- Analytical purity: 93%
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: No data
- Isomers composition: No data
- Purity test date: Not specified
- Lot/batch No.: 980035B
- Expiration date of the lot/batch: Not specified
- Stability under test conditions: Not specified
- Storage condition of test material: Not specified

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Covance Research Products, Inc Kalamazoo, MI)
- Age at study initiation: 3 months
- Weight at study initiation: 2.3-2.6 kg
- Housing: Not specified
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least 2 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 +/- 3 [OECD guidelines recommend 20+/- 3, but unlikely to affect outcome]
- Humidity (%): 40-60
- Air changes (per hr): 12-15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: Not specified within study report, OECD state that 'untreated skin areas of test animal serve as control'.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml

VEHICLE
Not applicable
Duration of treatment / exposure:
4 hours
Observation period:
4 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: ~6 cm2
- % coverage: Not specified
- Type of wrap if used: Gauze patch with cotton backing, held in place with an elastic rabbit jacket [OECD guideline 404 recommends semi occlusive wrap rather than occlusive, however occlusive wrap expected to increase any potential irritation]

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Wiped with a damp disposable towel after patch removed
- Time after start of exposure: 4 hours

SCORING SYSTEM: Graded 0 to 4 for erythema and edema

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
other: animals 1-3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Reversibility not applicable as no irritation seen
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
other: animals 1-3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Reversibility not applicable as no irritation seen
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No dermal irrritation seen in any animal at any point up to 72 hours after patch removal
Other effects:
No significant effect on body weights, no systemic toxicity observed [although the extent of examination is not specified]

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In a GLP study, conducted according to OECD guideline 404, an application of undiluted DEIPA (0.5 ml) resulted in no dermal irritation in New Zealand White rabbits.
Executive summary:

In a GLP study, conducted according to OECD guideline 404, the dermal irritation of DEIPA was assessed. Three New Zealand White rabbits received an application of 0.5 ml of undiluted DEIPA to clipped skin, which was subsequently covered for 4 hours by an occlusive patch followed by removal of the test material with a damp cloth. All rabbits were graded for erythema and edema at 24, 48 and 72 hours after patch removal.

 

No dermal irritation was exhibited in any of the rabbits. The application of DEIPA did not significantly affect body weights and no systemic toxicity was observed [although the extent of examination is not specified]. The study was terminated on day 4.

 

From the results of this well-conducted study, DEIPA can be considered as non-irritating to the skin of rabbits.