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Description of key information

Dimemethylisopropanolamine was found to be corrosive to the rabbit skin under occlusive conditions (comparable to OECD guideline 404, non-GLP). Dermal application for 5 min caused redness, scaling and necrosis, while at 15-minutes and 20-hour exposures severe necrosis was observed which was not fully reversible within 8 days.

Single application of undiluted test substance to the rabbit eye caused severe chemical burns on the eye (comparable to OECD guideline 405, non-GLP). Severe corneal opacity was observed throughout the study and was not reversible within 8 days.

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards, well documented and acceptable for assessment
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
Method: BASF-Test: Animals were treated for 1, 5, 15 min and 20 hours using occlusive conditions. An application site of 2.5x2.5 cm was covered with the liquid test substance. After the application time (1, 5 and 15 min) the skin was washed with Lutrol (50%). The animals were observed for 8 days and skin changes were recorded daily. The report describes findings after 24 hours and at the end of the observation period (8 days). For a final evaluation, the findings after 48 h and 72 h from the raw data were taken into account.
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: ca. 2.32 kg
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): ca. 0.5 g
Duration of treatment / exposure:
1, 5 and 15 minutes and 20 hours
Observation period:
8 days
Number of animals:
2 per exposure duration
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm

REMOVAL OF TEST SUBSTANCE
Washing might have been done with Lutrol and Lutrol/Water (50%/50%) at the end of the treatment (1, 5 and 15 minutes, 20 hours)

SCORING SYSTEM:
Similar to the one described in OECD 404 guideline
Irritation parameter:
erythema score
Remarks:
1 min exposure
Basis:
mean
Time point:
other: 24 h - 8 d
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: redness and scaling
Irritation parameter:
erythema score
Remarks:
5 min exposure
Basis:
mean
Time point:
other: 24 h - 8 d
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: redness, necrosis and scaling
Irritation parameter:
erythema score
Remarks:
15 min exposure
Basis:
mean
Time point:
other: 24 h - 8 d
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: redness and severe necrosis
Irritation parameter:
erythema score
Remarks:
20 h exposure
Basis:
mean
Time point:
other: 24 h - 8 d
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: redness and severe necrosis
Irritation parameter:
edema score
Remarks:
1, 5, 15 min exposure
Basis:
mean
Time point:
other: 24 h - 8 d
Score:
0
Max. score:
4
Irritation parameter:
edema score
Remarks:
20 h exposure
Basis:
mean
Time point:
other: 24 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritant / corrosive response data:
Full thickness necrosis of the skin was observed in animals when exposed to the test substance for 20 hours under occlusive conditions. In addition full thickness necrosis was observed in rabbits at the end of the observation period (8 days) when exposed to the test substance for 5 or 15 minutes under occlusive conditions. Exposure for 1 minute did not lead to necrosis.
Interpretation of results:
corrosive
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards, well documented and acceptable for assessment
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
Method: BASF-Test: 50 µL of the test substance were applied to the conjunctival sac of one eye in 2 animals. The animals were observed after 10 min, 1 and 3h on the day of treatment and up to 8 days afterwards. Findings were recorded daily. The eyes were not washed out after 24 hours as specified in OECD Guideline 405. The report describes findings after 1 and 24 hours and at the end of the observation period. For final evaluation, the findings after 48 and 72 hours from the raw data were taken into account.
GLP compliance:
no
Specific details on test material used for the study:
- Name of test material (as cited in study report): Dimethyl-isopropanolamin
- Physical state: liquid
no further data
Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: mean ca. 2.38 kg


ENVIRONMENTAL CONDITIONS
no data
Vehicle:
unchanged (no vehicle)
Controls:
other: 1 drop of 85% NaCl solution in the left eye
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.05 ml
Duration of treatment / exposure:
single application
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
2
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM:
similar to the one described in OECD guideline 405
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1 h - 24 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 8 d
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: staphyloma formation and severe necrosis
Irritation parameter:
conjunctivae score
Basis:
other:
Time point:
other: 1 h - 24 h
Remarks on result:
other: further scoring not possible due to brownish crustation
Irritant / corrosive response data:
Application of the test substance led to severe chemical burns on the eye. Corneal opacity grade 3-4 was observed throughout the study and was not reversible within 8 days.
Interpretation of results:
corrosive
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In a skin irritation test comparable to OECD guideline 404, dimemethylisopropanolamine was applied undiluted to the skin of Vienna White rabbits for 1, 5, 15 minutes or 20 hours under occlusive conditions (BASF AG, 1964). Observations took place at 24 hours and 8 days. Application for 1 minute caused redness and scaling. In animals exposed to the test substance for 5 and 15 minutes and 20 hours full thickness necrosis was observed that remained visible until the end of the observation period. Dimemethylisopropanolamine was judged corrosive to skin.

In an eye irritation test comparable to OECD guideline 405, 50 µL of the test substance was applied to the conjunctival sac of the eyes of 2 Vienna White rabbits (BASF AG, 1964). Animals were observed after 10 min, 1 and 3h on the day of treatment and at up to 8 days after the treatment. Application of the test substance led to severe chemical burns on the eye. Severe corneal opacity was observed throughout the study and was not reversible within 8 days. Dimemethylisopropanolamine was judged corrosive to eyes.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is considered to be classified for Skin Corr. 1B (H314: Causes severe skin burns and eye damage) and Eye Damage 1 (H318: Causes serious eye damage) under Regulation (EC) No. 1272/2008, as amended for the thirteenth time in Regulation (EU) No 2017/776.

 

Furthermore, 1-(dimethylamino)propan-2-ol is included in Annex VI of Regulation (EC) No. 1272/2008 with the following legal classification:

  • Skin Corr. 1B (H314: Causes severe skin burns and eye damage).

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