Registration Dossier

Administrative data

Description of key information

Effects on skin irritation/corrosion: corrosive
Effects on eye irritation: corrosive
Effects on respiratory irritation: irritating

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

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:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 3.2 kg
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
TEST MATERIAL
- Amount applied: approx. 0.5 ml
- Concentration: undiluted
Duration of treatment / exposure:
Dorsal skin: 1, 5, 15 minutes and 20 hours
Ear: 20 hours
Observation period:
8 days
Number of animals:
2
Details on study design:
TEST SITE
- Area of exposure: Dorsal skin and ear

REMOVAL OF TEST SUBSTANCE
- Washing: Lutrol 50%

SCORING SYSTEM:
- similar to the table contained in OECD TG 404
Time point:
48 h
Reversibility:
not reversible
Remarks on result:
other: necrosis

Skin reactions:

After removal of the test substance, bleeding in the skin was observed after 1, 5, 15min exposure.

Time of exposure

Findings after 24 h

Findings after 8 days

Dorsal skin

1 min

N+

N+/ N++ margin: ER++/ED++

5 min

N+

N++/margin: ER++/ED++

15 min

N+

N++/margin: ER++/ED++

20 h

N+/margin: ER++/ED++

N++/margin: ER++/ED++

Ear

20 h

N+++

Mummification

N = necrosis; ER = erythema; ED = edema; Ø = nonirritating; (+) = slight; + = distinct; ++ = severe; +++ = very severe

Interpretation of results:
Category 1B (corrosive) based on GHS criteria
Conclusions:
Skin necrosis was seen 48 hours after contact to tridecylamine for 1 (1 out of 2 animals), 5 or 15 minutes or 20 hours.
Endpoint:
skin corrosion: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
GLP compliance:
no
Test system:
human skin model
Vehicle:
unchanged (no vehicle)
Details on test system:
The test consists of a single topical exposure of the test substance to the surface of a human reconstituted epidermis model for 3 minutes and 1 hour followed by a cell viability test.
Cell viability is measured by dehydrogenase conversion of the yellow, water-soluble MTT (3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyltetrazolium bromide) present in cell mitochondria into a blue formazan salt that is measured quantitatively after isopropanol extraction from the tissues. The optical density of the extracts of the tissues treated with the test substance is compared to negative control values from tissues treated with deionized water and is expressed as relative tissue viability.
Two EpiDerm TM tissues per exposure time were treated with 50 μL liquid test substance.
In case of direct MTT reduction, two freeze-killed control tissues (KC) per exposure time were treated additionally with each, the test item and the negative control, in the same way as the viable tissues.
Based on the result of the pretest, it was judged that application of killed control tissues is necessary.

Negative control (NC): Deionized water
Positive control (PC): 8 N potassium hydroxide solution
MTT reduction control (KC): Deionized water or test substance
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
50 µL liquid test substance
Duration of treatment / exposure:
3 minutes, 1 hour
Number of replicates:
2
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
1st (3 minutes corrosion test)
Value:
35.7
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
1st (1 hour corrosion test)
Value:
21
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
2nd (3 minutes corrosion test)
Value:
59.6
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
2nd (1 hour corrosion test)
Value:
14
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
3rd (3 minutes corrosion test)
Value:
31.5
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
3rd (1 hour corrosion test)
Value:
13.4
Interpretation of results:
Category 1 (corrosive) based on GHS criteria
Conclusions:
Based on the results observed and by applying the evaluation criteria, it was concluded that Tridecylamine, branched and linear (TDA plus) shows a skin corrosion potential in the EpiDerm™ in vitro skin corrosion test under the test conditions chosen.
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:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
small volume of test substance (0.05 ml)
GLP compliance:
no
Species:
rabbit
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: mean 2.9 kg
Vehicle:
unchanged (no vehicle)
Controls:
other: second eye of the same animal treated with NaCl
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.05 ml
- Concentration: undiluted
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
2
Details on study design:
SCORING SYSTEM:
Eye reactions were scored similar to the table contained in OECD TG 405
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 hour
Score:
1
Max. score:
3
Reversibility:
not reversible
Remarks:
within 8 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1 hour
Score:
>= 3 - <= 4
Max. score:
4
Reversibility:
not reversible
Remarks:
within 8 days
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1 hour
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks:
within 8 days
Irritant / corrosive response data:
Corrosion was noted 1 and 24 h after application as substantiated by severe reddening, very severe edema, and severe corneal opacity. Severe chemosis was noted after 8 days. Cornea could not be examined due to suppuration.

Findings:

Findings after 1 hour

Findings after 24 hours

Findings after 8 days

Test substance:

Corrosion

R+/ED+++/OP++

Corrosion

R+/ED+++/OP++

ED++/severe suppuration; eyeball could not be evaluated

NaCl:

Ø

Ø

Ø

R = redness; ED = edema; OP = opacity; Ø = nonirritating; (+) = slight; + = distinct; ++ = severe; +++ = very severe

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Skin Irritation:

Rabbits were exposed for 1, 5, 15min, or 20h to the registered substance (BASF 1970). After removal of the test substance, bleeding in the skin was observed (e.g. Petechia). Full-thickness skin necrosis was observed following 48h in all rabbits except one of two animals exposed for 1 minute, which showed only superficial necrosis until the end of the observation period of 8 days.

Tridecylamine, branched and linear (TDA plus) shows a skin corrosion potential in the EpiDerm™ in vitro skin corrosion test under the test conditions chosen (BASF SE, 2018).

 

Eye Irritation:

Severe reddening, very severe edema, and severe corneal opacity were noted in the rabbit eye at 1 and 24 hours after instillation of a small volume (0.05 ml) of an undiluted TDA. After 8 days, strong edema and suppuration did not allow examination of the eyes and the study was terminated for the sake of animal welfare (BASF AG, 1970).

Respiratory Tract Irritation

The sensory irritation potential of TDA was studied with the mouse bioassay following the method of the American Society for Testing and Materials (BASF AG, 1998; Val. 2). Groups of 4 male Swiss mice were exposed head-only to TDA (3.8, 7.7, 23 and 90 mg/m3) for 45 minutes, followed by a recovery phase of 15 minutes and a 7 day post-exposure observation period. Breathing patterns and frequency were recorded pre-exposure and during exposure in whole-body plethysmographs and the concentrations that produced a 50% decrease in frequency rates (RD50) during early, middle, and late 10-minute exposure intervals were calculated from the dose response. Clinical signs were only seen in the groups exposed to 23 or 90 mg/m³ (piloerection, poor condition of animals, and - at 90 mg/m3 only - labored breathing). The RD50s were calculated to be 525.6 mg/m3, 37.4 mg/m3 and 30.4 mg/m3 for the early, middle and late exposure periods, respectively. The respiratory depression was not fully reversible after the recovery phase at any of the tested concentrations. From the pattern of RD50 and the macroscopic lung findings in 2 mice exposed to 90 mg/m3 (focal red discoloration in some lobes of the lung), it was concluded that tridecylamine leads mainly to pulmonary irritation.

 

Justification for classification or non-classification

Based on the results of the skin and eye irritation testing, the test item is classified as skin corrosive cat. 1B (H314) and causes serious eye damage cat. 1 (H318) according to Regulation (EC) No 1272/2008 (CLP).

In mice, pulmonary irritation was observed in a study detecting respiratory depression. Additionally, acute inhalation caused irritation (bloody secretions from nose and eyes) in rats. Since no mortality occured, no signs of corrosion were described, and due to the low vapour pressure of the substance, which - in the absence of spray applications - limits exposure, classification for STOT SE 3 (irritation to the respiratory tract) is justified, but EUH 071 is not assigned.